68 Quality Engineer jobs in Ireland
Manufacturing Engineer/Quality Engineer
Clonmel, Munster
Abbott
Posted 28 days ago
Job Viewed
Job Description
**Have you ever wanted to make a difference?**
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.
**Abbott Ireland**
In Ireland, Abbott employs over 6,000 people across ten sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
**Vascular Division Clonmel**
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Our broad line of vascular devices-which includes vessel closure, endovascular and coronary technologies-are used to treat vessel diseases of the heart, carotid arteries, and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia, and other serious vascular conditions.
**We are currently looking for Manufacturing Engineers and Quality Engineers to join our modern site in Clonmel.**
**This is how you will make a difference:**
As a Manufacturing Engineer, you will be responsible for engineering support of manufacturing operations, which will involve key engineering metric management and process optimization activities including Manufacturing Yield improvement, product quality monitoring, lean manufacturing design and material/equipment/process troubleshooting using continuous improvement tools and methodology. Working as part of the operations support team, the manufacturing engineer will liaise with operations, quality, R&D and materials & purchasing departments to ensure quality and efficient manufacturing operations.
**Main responsibilities**
+ Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company.
+ Prepares reports, publishes, and makes presentations to communicate findings.
+ Analyses and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
+ Understands engineering principles theories, concepts, practices and techniques.
+ Understands the business needs of the company, and has knowledge of the customer needs of our business.
+ Understands the business cycle and foresight of emerging technologies trends.
+ Cultivates internal and external network of resources to complete tasks. Serves as a resource in the selection orientation and training of new engineers and employees.
+ May lead a project team, determining goals and objectives for the projects.
+ Mentors employees by sharing technical expertise and providing feedback and guidance.
+ Interacts cross functionally and with internal and external customers.
+ Serves as a consultant for engineering or scientific interpretations and advice on significant matters.
+ Acts as a spokesperson to customers on business unit current and future capabilities.
+ Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
**Experience, Education and Skills Required - Manufacturing Engineer:**
+ National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline.2+ years of related work experience, or an equivalent combination of education and work experience.
+ Basic technical knowledge of concepts, practices and procedures. Limited understanding of business unit/group function.
+ Learns to use professional concepts and company policies and procedures to solve routine problems.
+ Developing a network of internal resources to facilitate completion of tasks.
**JOB DESCRIPTION:**
**About Abbott**
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
**Abbott Ireland Vascular Division Clonmel**
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development and advancing medicine through training and education.
Our broad line of vascular devices-which includes vessel closure, endovascular and coronary technologies-are used to treat vessel diseases of the heart, carotid arteries and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia and other serious vascular conditions.
**Purpose Statement:**
Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
Shift Role: 2-cycle shift (8-16:30 and 16:30-00:30)
**Key Responsibilities - Quality Engineer:**
1. Identifies manufacturing process defects (scrap, non-conforming material, customer complaints) by dispositioning non-conforming material, identifying primary root causes and suggesting corrective and preventative actions. May be responsible for querying and bounding data to support implementation of basic product stops.
2. Assists in development of product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses, Failure Mode Effect Analysis (FMEA) in conjunction with other product development team members. May be responsible for providing input to risk analyses and Failure Mode Effect Analysis' (FMEAs).
3. Becomes skilled at using process monitoring systems by starting to identify critical process steps and applying basic methods to reduce process variation to reduce/eliminate the cause of defects.
4. Assists product/process improvement efforts (example, scrap, nonconforming product, customer complaints) by systematically gathering quality metric data based on previous program templates and by assisting in the appropriate analysis methods to enhance sustaining product design and new product development.
5. Becomes skilled at using quality tools and training materials by working with existing quality tools and training materials and by understanding evolution/history of tools in use.
6. Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
7. Participates in corrective and preventive action activity.
8. Participates in Field Discrepancy Notification (FDN) investigations.
**Education & Job Skills - Quality Engineer**
+ (Education/ Experience) National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline. 2+ years of related work experience, or an equivalent combination of education and work experience.
+ (Technical/Business Knowledge (Job Skills)) Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
+ (Cognitive Skills) Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.
+ (Influence/Leadership) Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks. May lead a project team of moderate scope. Provides guidance to less experienced staff. Acts as a mentor to lower level individual contributors. Influence exerted at peer level and occasionally at first levels of management.
+ (Planning/Organisation) Plans, organises, and prioritises own daily work routine to meet established schedule.
+ (Decision Making/Impact) Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.
+ (Supervision Provided) May provide limited work direction and guidance to exempt and/or skilled nonexempt levels of employees, may be asked to evaluate performance of and assist in career development planning for subordinates.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.
**Abbott Ireland**
In Ireland, Abbott employs over 6,000 people across ten sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
**Vascular Division Clonmel**
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Our broad line of vascular devices-which includes vessel closure, endovascular and coronary technologies-are used to treat vessel diseases of the heart, carotid arteries, and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia, and other serious vascular conditions.
**We are currently looking for Manufacturing Engineers and Quality Engineers to join our modern site in Clonmel.**
**This is how you will make a difference:**
As a Manufacturing Engineer, you will be responsible for engineering support of manufacturing operations, which will involve key engineering metric management and process optimization activities including Manufacturing Yield improvement, product quality monitoring, lean manufacturing design and material/equipment/process troubleshooting using continuous improvement tools and methodology. Working as part of the operations support team, the manufacturing engineer will liaise with operations, quality, R&D and materials & purchasing departments to ensure quality and efficient manufacturing operations.
**Main responsibilities**
+ Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company.
+ Prepares reports, publishes, and makes presentations to communicate findings.
+ Analyses and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
+ Understands engineering principles theories, concepts, practices and techniques.
+ Understands the business needs of the company, and has knowledge of the customer needs of our business.
+ Understands the business cycle and foresight of emerging technologies trends.
+ Cultivates internal and external network of resources to complete tasks. Serves as a resource in the selection orientation and training of new engineers and employees.
+ May lead a project team, determining goals and objectives for the projects.
+ Mentors employees by sharing technical expertise and providing feedback and guidance.
+ Interacts cross functionally and with internal and external customers.
+ Serves as a consultant for engineering or scientific interpretations and advice on significant matters.
+ Acts as a spokesperson to customers on business unit current and future capabilities.
+ Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
**Experience, Education and Skills Required - Manufacturing Engineer:**
+ National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline.2+ years of related work experience, or an equivalent combination of education and work experience.
+ Basic technical knowledge of concepts, practices and procedures. Limited understanding of business unit/group function.
+ Learns to use professional concepts and company policies and procedures to solve routine problems.
+ Developing a network of internal resources to facilitate completion of tasks.
**JOB DESCRIPTION:**
**About Abbott**
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
**Abbott Ireland Vascular Division Clonmel**
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development and advancing medicine through training and education.
Our broad line of vascular devices-which includes vessel closure, endovascular and coronary technologies-are used to treat vessel diseases of the heart, carotid arteries and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia and other serious vascular conditions.
**Purpose Statement:**
Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
Shift Role: 2-cycle shift (8-16:30 and 16:30-00:30)
**Key Responsibilities - Quality Engineer:**
1. Identifies manufacturing process defects (scrap, non-conforming material, customer complaints) by dispositioning non-conforming material, identifying primary root causes and suggesting corrective and preventative actions. May be responsible for querying and bounding data to support implementation of basic product stops.
2. Assists in development of product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses, Failure Mode Effect Analysis (FMEA) in conjunction with other product development team members. May be responsible for providing input to risk analyses and Failure Mode Effect Analysis' (FMEAs).
3. Becomes skilled at using process monitoring systems by starting to identify critical process steps and applying basic methods to reduce process variation to reduce/eliminate the cause of defects.
4. Assists product/process improvement efforts (example, scrap, nonconforming product, customer complaints) by systematically gathering quality metric data based on previous program templates and by assisting in the appropriate analysis methods to enhance sustaining product design and new product development.
5. Becomes skilled at using quality tools and training materials by working with existing quality tools and training materials and by understanding evolution/history of tools in use.
6. Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
7. Participates in corrective and preventive action activity.
8. Participates in Field Discrepancy Notification (FDN) investigations.
**Education & Job Skills - Quality Engineer**
+ (Education/ Experience) National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline. 2+ years of related work experience, or an equivalent combination of education and work experience.
+ (Technical/Business Knowledge (Job Skills)) Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
+ (Cognitive Skills) Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.
+ (Influence/Leadership) Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks. May lead a project team of moderate scope. Provides guidance to less experienced staff. Acts as a mentor to lower level individual contributors. Influence exerted at peer level and occasionally at first levels of management.
+ (Planning/Organisation) Plans, organises, and prioritises own daily work routine to meet established schedule.
+ (Decision Making/Impact) Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.
+ (Supervision Provided) May provide limited work direction and guidance to exempt and/or skilled nonexempt levels of employees, may be asked to evaluate performance of and assist in career development planning for subordinates.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.
0
Quality Engineer
Cork, Munster
Stryker
Posted 4 days ago
Job Viewed
Job Description
**18 Month FTC**
**Position Summary**
Provide quality engineering support in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.
**Position Requirements**
Will work within the quality operations team, with moderate supervision and mentoring, with responsibility for quality related activities, including, but not limited to the following:
+ Work closely with operations and the business functions to ensure quality performance of product and processes.
+ Approval of NC, builds proficient in problem solving and root causing activities.
+ Participate in the development and improvement of the manufacturing processes for existing and new products.
+ Review of change management activities.
+ Maintain KPIs for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
+ Support execution and analysis of QATs.
+ Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction and mitigation.
+ Develop understanding of risk management practices and concepts, ability to become proficiency in process risk.
+ Develop understanding of optimization of inspection methods and sampling. Support First Article Inspections.
+ Developing proficiency in statistical methods and application.
+ Participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audits preparation building confidence and proficiency in interactions with same.
+ Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.
+ Support manufacturing transfers to other plants/facilities, execution quality activities.
+ Responsible for initiation, internal containment and support of ship and product holds for potential product escapes.
**Qualification Knowledge Skills**
+ Masters or Bachelor of Science, Engineering or related subject
+ Previous experience in industry desirable
+ Understanding of Med Device concepts desirable.
+ Familiarity with ISO 13485, GDP, GMP concept desirable.
+ Excellent communication skills and attention to detail.
+ Have a good understanding of engineering and quality concepts / theories.
+ High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
+ Self-starter with efficient work style and ability to handle multiple tasks in a fast paced environment.
+ Must be willing to work as part of a multi-site team, with some travel required.
+ Knowledge of Risk Based and statistical concepts desirable.
+ Problem solving and analytical skills.
+ Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
+ Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
+ Accepts change openly and adopts a continuous improvement orientation to the role
+ Excellent English (both oral and written)
+ Ability to be the voice of Quality when dealing cross functionally
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
**Position Summary**
Provide quality engineering support in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.
**Position Requirements**
Will work within the quality operations team, with moderate supervision and mentoring, with responsibility for quality related activities, including, but not limited to the following:
+ Work closely with operations and the business functions to ensure quality performance of product and processes.
+ Approval of NC, builds proficient in problem solving and root causing activities.
+ Participate in the development and improvement of the manufacturing processes for existing and new products.
+ Review of change management activities.
+ Maintain KPIs for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
+ Support execution and analysis of QATs.
+ Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction and mitigation.
+ Develop understanding of risk management practices and concepts, ability to become proficiency in process risk.
+ Develop understanding of optimization of inspection methods and sampling. Support First Article Inspections.
+ Developing proficiency in statistical methods and application.
+ Participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audits preparation building confidence and proficiency in interactions with same.
+ Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.
+ Support manufacturing transfers to other plants/facilities, execution quality activities.
+ Responsible for initiation, internal containment and support of ship and product holds for potential product escapes.
**Qualification Knowledge Skills**
+ Masters or Bachelor of Science, Engineering or related subject
+ Previous experience in industry desirable
+ Understanding of Med Device concepts desirable.
+ Familiarity with ISO 13485, GDP, GMP concept desirable.
+ Excellent communication skills and attention to detail.
+ Have a good understanding of engineering and quality concepts / theories.
+ High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
+ Self-starter with efficient work style and ability to handle multiple tasks in a fast paced environment.
+ Must be willing to work as part of a multi-site team, with some travel required.
+ Knowledge of Risk Based and statistical concepts desirable.
+ Problem solving and analytical skills.
+ Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
+ Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
+ Accepts change openly and adopts a continuous improvement orientation to the role
+ Excellent English (both oral and written)
+ Ability to be the voice of Quality when dealing cross functionally
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
This advertiser has chosen not to accept applicants from your region.
1
Quality Engineer
Dún Laoghaire, Leinster
embecta
Posted 5 days ago
Job Viewed
Job Description
embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn , Facebook , Instagram and X ( .
**Why join us?**
A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees.
Reporting to the Quality Operations Manager, this role supports product and process development, non-conformance investigations, lot disposition, and the application of SPC to production. Responsibilities include coordinating with QA/QC labs, approving validation studies, managing complaint investigations, supporting change controls, and leading or contributing to process improvements. The role also involves preparing, reviewing, and approving technical documentation.
**Responsibilities:**
+ Managing the activities of the Quality Inspectors to ensure optimal efficiency and compliance with all regulatory requirements;
+ Drive root cause analysis of non-conformances with relevant personnel and ensure corrections are implemented before starting back to production after a quality issue;
+ Drive and maintain cGMP practices across all operational departments under your quality responsibility (Incoming, assembly, packaging, warehouse) and attend departmental and other meetings as appropriate;
+ Release batches in SAP from packaging to sterilization and final release & Complete DHR reviews and batch releases;
+ Liaise with relevant personnel regarding flow of product through QC department and other issues that arise;
+ Review, analyze and report on relevant customer complaints and institute corrective actions.
**Education & Experience**
+ A degree in a Science/Engineering discipline (Preferably Polymer Science/Engineering or Mechanical Engineering).
+ Previous work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.
+ Experience of preparing technical documentation and a good knowledge of Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).
+ Experience in CAPA system management and a working knowledge of FDA requirements and managing FDA audits. Good knowledge of SAP and Track wise
+ Previous experience of working in process validation and a clean room environment .
+ The ability to work within a cross functional team
+ Excellent interpersonal and communication skills coupled with a high level of computer literacy.
Regular
embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
**Why join us?**
A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees.
Reporting to the Quality Operations Manager, this role supports product and process development, non-conformance investigations, lot disposition, and the application of SPC to production. Responsibilities include coordinating with QA/QC labs, approving validation studies, managing complaint investigations, supporting change controls, and leading or contributing to process improvements. The role also involves preparing, reviewing, and approving technical documentation.
**Responsibilities:**
+ Managing the activities of the Quality Inspectors to ensure optimal efficiency and compliance with all regulatory requirements;
+ Drive root cause analysis of non-conformances with relevant personnel and ensure corrections are implemented before starting back to production after a quality issue;
+ Drive and maintain cGMP practices across all operational departments under your quality responsibility (Incoming, assembly, packaging, warehouse) and attend departmental and other meetings as appropriate;
+ Release batches in SAP from packaging to sterilization and final release & Complete DHR reviews and batch releases;
+ Liaise with relevant personnel regarding flow of product through QC department and other issues that arise;
+ Review, analyze and report on relevant customer complaints and institute corrective actions.
**Education & Experience**
+ A degree in a Science/Engineering discipline (Preferably Polymer Science/Engineering or Mechanical Engineering).
+ Previous work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.
+ Experience of preparing technical documentation and a good knowledge of Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).
+ Experience in CAPA system management and a working knowledge of FDA requirements and managing FDA audits. Good knowledge of SAP and Track wise
+ Previous experience of working in process validation and a clean room environment .
+ The ability to work within a cross functional team
+ Excellent interpersonal and communication skills coupled with a high level of computer literacy.
Regular
embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
This advertiser has chosen not to accept applicants from your region.
2
Quality Engineer
Cork, Munster
Stryker
Posted 10 days ago
Job Viewed
Job Description
Job Title
**Engineer, Quality**
Reports To
**Associate Manager/ Manager/ Senior Manager, Quality Assurance**
**Position Summary**
Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.
**What You'll Do:**
Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
Work closely with operations and the business functions to ensure quality performance of product and processes.
Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
Analysis and review of concession requests.
Review and approval of change management activities.
Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
Support execution and analysis of QATs.
Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
Proficiency in statistical methods and application.
Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
Assist in the development, responsible for review & approval of process and equipment validation/qualification.
Support manufacturing transfers to other plants/facilities, leading quality activities.
Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
Coach and mentor others in quality topics and activities.
**What You'll Need:**
Bachelor's/Level 8 degree in Science or Engineering
0-2 years similar experience
Keen eye for detail
Strong communication skills
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
**Engineer, Quality**
Reports To
**Associate Manager/ Manager/ Senior Manager, Quality Assurance**
**Position Summary**
Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.
**What You'll Do:**
Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
Work closely with operations and the business functions to ensure quality performance of product and processes.
Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
Analysis and review of concession requests.
Review and approval of change management activities.
Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
Support execution and analysis of QATs.
Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
Proficiency in statistical methods and application.
Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
Assist in the development, responsible for review & approval of process and equipment validation/qualification.
Support manufacturing transfers to other plants/facilities, leading quality activities.
Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
Coach and mentor others in quality topics and activities.
**What You'll Need:**
Bachelor's/Level 8 degree in Science or Engineering
0-2 years similar experience
Keen eye for detail
Strong communication skills
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
This advertiser has chosen not to accept applicants from your region.
3
Quality Engineer
Cork, Munster
Stryker
Posted 10 days ago
Job Viewed
Job Description
**Position Requirements**
**Engineer, Quality**
Reports To
**Associate Manager/ Manager/ Senior Manager, Quality Assurance**
**Position Summary**
Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.
**Position Requirements**
Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
Work closely with operations and the business functions to ensure quality performance of product and processes.
Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
Analysis and review of concession requests.
Review and approval of change management activities.
Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
Support execution and analysis of QATs.
Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
Proficiency in statistical methods and application.
Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
Assist in the development, responsible for review & approval of process and equipment validation/qualification.
Support manufacturing transfers to other plants/facilities, leading quality activities.
Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
Coach and mentor others in quality topics and activities.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
**Engineer, Quality**
Reports To
**Associate Manager/ Manager/ Senior Manager, Quality Assurance**
**Position Summary**
Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.
**Position Requirements**
Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
Work closely with operations and the business functions to ensure quality performance of product and processes.
Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
Analysis and review of concession requests.
Review and approval of change management activities.
Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
Support execution and analysis of QATs.
Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
Proficiency in statistical methods and application.
Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
Assist in the development, responsible for review & approval of process and equipment validation/qualification.
Support manufacturing transfers to other plants/facilities, leading quality activities.
Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
Coach and mentor others in quality topics and activities.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
This advertiser has chosen not to accept applicants from your region.
4
Quality Engineer
Limerick, Munster
Stryker
Posted 28 days ago
Job Viewed
Job Description
**18 Month FTC**
**Position Summary**
Provide quality engineering support in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.
**Position Requirements**
Will work within the quality operations team, with moderate supervision and mentoring, with responsibility for quality related activities, including, but not limited to the following:
+ Work closely with operations and the business functions to ensure quality performance of product and processes.
+ Approval of NC, builds proficient in problem solving and root causing activities.
+ Participate in the development and improvement of the manufacturing processes for existing and new products.
+ Review of change management activities.
+ Maintain KPIs for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
+ Support execution and analysis of QATs.
+ Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction and mitigation.
+ Develop understanding of risk management practices and concepts, ability to become proficiency in process risk.
+ Develop understanding of optimization of inspection methods and sampling. Support First Article Inspections.
+ Developing proficiency in statistical methods and application.
+ Participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audits preparation building confidence and proficiency in interactions with same.
+ Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.
+ Support manufacturing transfers to other plants/facilities, execution quality activities.
+ Responsible for initiation, internal containment and support of ship and product holds for potential product escapes.
**Qualification Knowledge Skills**
+ Masters or Bachelor of Science, Engineering or related subject
+ Previous experience in industry desirable
+ Understanding of Med Device concepts desirable.
+ Familiarity with ISO 13485, GDP, GMP concept desirable.
+ Excellent communication skills and attention to detail.
+ Have a good understanding of engineering and quality concepts / theories.
+ High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
+ Self-starter with efficient work style and ability to handle multiple tasks in a fast paced environment.
+ Must be willing to work as part of a multi-site team, with some travel required.
+ Knowledge of Risk Based and statistical concepts desirable.
+ Problem solving and analytical skills.
+ Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
+ Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
+ Accepts change openly and adopts a continuous improvement orientation to the role
+ Excellent English (both oral and written)
+ Ability to be the voice of Quality when dealing cross functionally
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
**Position Summary**
Provide quality engineering support in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.
**Position Requirements**
Will work within the quality operations team, with moderate supervision and mentoring, with responsibility for quality related activities, including, but not limited to the following:
+ Work closely with operations and the business functions to ensure quality performance of product and processes.
+ Approval of NC, builds proficient in problem solving and root causing activities.
+ Participate in the development and improvement of the manufacturing processes for existing and new products.
+ Review of change management activities.
+ Maintain KPIs for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
+ Support execution and analysis of QATs.
+ Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction and mitigation.
+ Develop understanding of risk management practices and concepts, ability to become proficiency in process risk.
+ Develop understanding of optimization of inspection methods and sampling. Support First Article Inspections.
+ Developing proficiency in statistical methods and application.
+ Participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audits preparation building confidence and proficiency in interactions with same.
+ Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.
+ Support manufacturing transfers to other plants/facilities, execution quality activities.
+ Responsible for initiation, internal containment and support of ship and product holds for potential product escapes.
**Qualification Knowledge Skills**
+ Masters or Bachelor of Science, Engineering or related subject
+ Previous experience in industry desirable
+ Understanding of Med Device concepts desirable.
+ Familiarity with ISO 13485, GDP, GMP concept desirable.
+ Excellent communication skills and attention to detail.
+ Have a good understanding of engineering and quality concepts / theories.
+ High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
+ Self-starter with efficient work style and ability to handle multiple tasks in a fast paced environment.
+ Must be willing to work as part of a multi-site team, with some travel required.
+ Knowledge of Risk Based and statistical concepts desirable.
+ Problem solving and analytical skills.
+ Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
+ Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
+ Accepts change openly and adopts a continuous improvement orientation to the role
+ Excellent English (both oral and written)
+ Ability to be the voice of Quality when dealing cross functionally
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
This advertiser has chosen not to accept applicants from your region.
5
Quality Engineer
Galway, Connacht
Cregg Group
Posted 3 days ago
Job Viewed
Job Description
Quality Engineer East Galway Permanent This role would suit an experienced hands-on Quality Engineer or Supervisor that has a strong ability to work on their own initiative and is looking for long term career growth. A Quality Manager that is looking for a new challenge will also be considered. This job will be ideal for someone working in an Industrial engineering / manufacturing environment or someone looking for a move away from a very regulated environment. The role You will support and enhance quality systems to ensure compliance with industry standards (AS9100, ISO9001, ISO14001). Youll be involved in everything from audits and customer visits to day-to-day problem solving on the floor. Over time, you will take on more responsibility, including hosting audits and managing customer quality relationships as the role grows into more of a leadership position. Key Responsibilities Maintain, support, and develop the companys Quality Management System. Ensure compliance with industry standards and regulatory requirements (AS9100, ISO9001, ISO14001). Support and coordinate internal/external audits and maintain relevant certifications. Monitor and report on quality KPIs and drive continuous improvement. Work closely with production and engineering teams to embed a quality-first mindset. Investigate non-conformances, support root cause analysis, and implement corrective actions. Liaise with customers on quality-related issues Provide training and guidance to production teams to strengthen a culture of quality. Requirements Experience in a Quality Engineer, Quality Supervisor, or similar role within manufacturing/engineering. Knowledge of quality systems and standards (AS9100, ISO9001 essential; ISO14001 desirable). Auditing qualification is advantageous but not essential. Strong analytical, problem-solving, and organisational skills. Excellent communication skills, confident in working with colleagues and customers. A self-starter, able to work independently and on own initiative. Relevant qualification in Quality, Engineering, or related discipline. Please contact me for a confidential discussion or to discuss further. Deirdre Sheehan Skills: Quality Engineering Industrial Benefits: Mobile phone Paid Holidays Canteen Parking Pension Laptop
This advertiser has chosen not to accept applicants from your region.
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6
Quality Engineer
Galway, Connacht
TEAM HORIZON
Posted 6 days ago
Job Viewed
Job Description
Team Horizon is seeking a Quality Engineerto join our clients Engineering team at a GMP-regulated biopharmaceutical facility in Ireland. This role supports engineering projects and day-to-day operations with a strong focus on compliance, validation, and quality risk management. The Quality Engineer acts as a key interface between Engineering and Quality functions to ensure all systems and processes meet EU GMP standards and are inspection ready. Why you should apply: This role supports engineering projects and day-to-day operations with a strong focus on compliance, validation, and quality risk management. As Quality Engineer, you will act as a key interface between Engineering and Quality functions to ensure all systems and processes meet EU GMP standards and are inspection ready. What you will be doing: Ensure engineering activities are carried out in compliance with GMP and site quality standards. Provide oversight for equipment qualification, utility validation, facility modifications, and engineering change controls. Support the commissioning and qualification (C&Q) lifecycle, including document review and approval of protocols (IQ/OQ/PQ), risk assessments, and summary reports. Lead or support investigations related to engineering deviations, non-conformances, and CAPAs ensuring timely closure and root cause identification. Participate in cross-functional project teams for new equipment introduction, process improvements, and site upgrades, ensuring quality is embedded throughout. Act as quality representative within engineering-led initiatives (e.g., reliability improvements, energy efficiency upgrades). Support preparation for regulatory inspections (e.g. HPRA) and internal audits relating to engineering systems and GMP compliance. Maintain and improve engineering quality processes, such as document control, calibration systems, and preventative maintenance compliance. Undertake other tasks as assigned by the engineering manager. What you need to apply: Degree in Engineering, Life Sciences, or related technical discipline. 5+ years experience in a GMP-regulated pharmaceutical, biopharma, or medical device environment. Strong knowledge of validation principles, engineering best practices, and regulatory requirements under GMP. Hands-on experience with C&Q documentation, risk-based validation, and change management processes. Familiarity with engineering systems such as CMMS (eMaint), BMS (IQ vision), and automated manufacturing equipment is a plus. Proven ability to work effectively on their own initiative as well as effectively contributing to the team environment Experience working in a matrix role bridging Engineering and Quality departments. Knowledge of ISPE Baseline Guides, GAMP 5, and data integrity best practices. Six Sigma / Lean certification is advantageous. Strong understanding of GMP compliance and quality standards Strong Experience of using electronic and physical documentation systemsExcellent attention to detail and significant document review experience essential Excellent technical writing skills including deviation investigation reports and SOPs Skills: GMP C&Q Gamp 5 Regulatory Compliance Documention Benefits: Bonus, Pension, Healthcare
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7
Quality Engineer
Dunboyne, Leinster
BMS Recruitment
Posted 7 days ago
Job Viewed
Job Description
QUALITY ENGINEER Our client, a precision engineering and manufacturing company, is seeking a Quality Engineer to join their team in Meath. This is a permanent position offering an attractive salary, strong benefits, and long-term career prospects. COMPANY: Our client is a highly respected manufacturer of precision-engineered components for international markets. Operating from a modern facility in Meath, they supply high-quality parts to the industrial, construction, and machinery sectors. With continued growth, they are now looking to strengthen their quality team with an experienced Quality Engineer. THE ROLE: The Meath-based Quality Engineer will be responsible for: Performing inspection and measurement activities using CMM equipment and other quality tools. Developing and running CMM programs to ensure dimensional accuracy of manufactured parts. Reviewing engineering drawings and CAD models to verify dimensions and tolerances. Supporting root cause analysis, corrective actions, and continuous improvement initiatives. Maintaining accurate quality documentation and inspection reports. Working closely with production and engineering teams to uphold quality standards. THE PERSON: Our client is seeking candidates who: Have experience in a Quality Engineer or Quality Technician role within a manufacturing or engineering environment. Are confident with CMM programming and operation. Possess strong knowledge of GD&T (Geometric Dimensioning & Tolerancing). Have excellent attention to detail and a structured approach to problem-solving. Are collaborative team players with strong communication skills. THE PACKAGE: Salary: €30,000 - €40,000 (DOE) Contract: Full-time, permanent Pension: Contributory pension scheme Other: Overtime and training opportunities available LOCATION: Meath (commutable from Louth, Westmeath, Cavan, North Dublin) BMS Performance specialises in recruiting Quality and Engineering professionals across Ireland. We connect skilled candidates with employers who offer both stability and growth. To apply or learn more, contact Ross Wilkinson today. Skills: leinster meath cnc milling turning quality Benefits: pension
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8
Quality Engineer
Dublin, Leinster
Embecta
Posted 10 days ago
Job Viewed
Job Description
embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. Reporting to the Quality Operations Manager, this role supports product and process development, non-conformance investigations, lot disposition, and the application of SPC to production. Responsibilities include coordinating with QA/QC labs, approving validation studies, managing complaint investigations, supporting change controls, and leading or contributing to process improvements. The role also involves preparing, reviewing, and approving technical documentation. Responsibilities: Managing the activities of the Quality Inspectors to ensure optimal efficiency and compliance with all regulatory requirements; Drive root cause analysis of non-conformances with relevant personnel and ensure corrections are implemented before starting back to production after a quality issue; Drive and maintain cGMP practices across all operational departments under your quality responsibility (Incoming, assembly, packaging, warehouse) and attend departmental and other meetings as appropriate; Release batches in SAP from packaging to sterilization and final release & Complete DHR reviews and batch releases; Liaise with relevant personnel regarding flow of product through QC department and other issues that arise; Review, analyze and report on relevant customer complaints and institute corrective actions. Education & Experience A degree in a Science/Engineering discipline (Preferably Polymer Science/Engineering or Mechanical Engineering). Previous work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry. Experience of preparing technical documentation and a good knowledge of Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous). Experience in CAPA system management and a working knowledge of FDA requirements and managing FDA audits. Good knowledge of SAP and Track wise Previous experience of working in process validation and a clean room environment . The ability to work within a cross functional team Excellent interpersonal and communication skills coupled with a high level of computer literacy. Regular embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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9