112 Quality Engineer Ii jobs in Ireland

Quality Engineer II

New Ross, Leinster Integer Holdings Corporation

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Job Description

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers’ success

We create better solutions

We create success together

Inclusion

We always interact with others respectfully

We are open and honest with one another

Integrity

We do the right things and do things right

What you will do in this role:

The primary purpose of this position is to support the Life Sciences group in one or more of the following areas: sterilization, environmental monitoring, product cleanliness, and biocompatibility. In this role, you will ensure that Integer’s Life Science requirements are met or exceeded with occasional direction, instruction and guidance from more experienced associates and managers in your organization. You will continue to learn the application of microbiological and biocompatibility concepts in the manufacturing of a medical device.

· Adheres to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.

Support Life Sciences Activities

· You will generally work independently with occasional guidance from experienced Life Science mentors and managers to review and apply the applicable standards and procedures, to provide support in one or more of the following areas: sterilization, environmental monitoring, product cleanliness, and biocompatibility.

· You will write and review protocols, reports, and other documents related to sterilization, microbiological test methods, and/ or biocompatibility.

· You will perform work on technical projects, where you will follow Integer’s standard quality management, production system and/ or laboratory methodologies, to evaluate, maintain and improve the quality of medical devices.

· You will apply standard data analysis practices and techniques, under guidance of experienced Life Sciences associates, to establish root cause for out of specification results, and to support the justification for improvements.

· You are expected to collaborate with others in the exchange of information, ask questions, and regularly confirm your understanding with Life Science mentors, in support of your development as a Life Science associate.

· You may perform other duties as needed and as directed by your line of supervision.

Support Quality and Manufacturing Excellent Imperatives

· You embed Quality within all that you do – “I own Quality.” You are a standard bearer for Quality in

Reports To: Quality Manager or Senior Manager, Global Life Sciences

Location: Varies Career Band Level: P2

Job Group: Quality Exemption Status: Exempt

Job Group Family: Life Sciences Date Revised: May 2023

everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI’s and journey differentiated quality.

· Provide support of Integer’s Manufacturing Excellence and Market Focused Innovation Strategies

· Participation or leadership through Site Hoshin Plans, Quality Plans, Validation master plans, associated quality improvement imperatives

· Provide leadership as required for QA RA weekly and monthly metrics, supporting the walk to 5 sigma.

· Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required.

· Support the standardization through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable.

· Associate Engagement promoted through the adoption of standardized problem solving. methodologies, behavior-based safety programs, and improvement idea and suggestion systems.

· Systems & Process Optimization through adoption of principles of built in quality.

How you will be measured:

The specific measures listed below may be subject to change and are not intended to be an all-inclusive list.

· Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs.

· You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.

· Quality – Achievement of site Quality KPIs

· Innovation and ideation are critical aspects of your role and you will be expected to generate continuous improvement suggestions and support the implementation of them.

What sets you apart:

· You have earned, as a minimum, a bachelor’s degree in Biology, Microbiology, or related technical field, and have at least 3 years of experience.

· If you do not meet the education requirements, you may be considered with 7+ years of relevant experience.

· While you will have occasional support and guidance from more experienced Life Science associates, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams.

· You will demonstrate a solid technical aptitude with the ability to be an effective contributor to the team or produce results of a technical nature as an individual.

· You will demonstrate competencies in both written and oral communication.

· You maintain a calm demeanor that transcends the high energy, constantly changing product environment.

· You possess a positive, can-do attitude with an underlying belief that failure is not an option.

Working Conditions:

· The working environment varies from a standard office environment to laboratory and production areas including cleanrooms with varying physical conditions, gowning requirements and high noise levels.

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.

About Us

Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company’s brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at .

Integer Holdings Corporation (“Integer”) is an equal opportunity employer. We do not discriminate based on race, color, sex, religion, national origin, and on any other protected characteristics. We celebrate our many differences and remain committed to providing an inclusive workplace free from harassment and discrimination.

Integer does not discriminate against any applicants or employees because he or she is a disabled veteran, Armed Forces service medal veteran, recently separated veteran, or active-duty wartime veteran, campaign badge veteran, referred to collectively as "Protected Veterans." It is also the policy of Integer to employ and to advance in employment, all people regardless of their status as individuals with disabilities. All employment decisions are based only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship, at all levels of employment.

Additionally, Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons. If you are interested in applying for an employment opportunity with Integer and believe you will need an accommodation for the application or job interview processes, please contact us at + or via so that we may discuss appropriate adjustments to our processes to enable you to be considered for a job opening. This phone number and email address is strictly for the purpose of making a request for an accommodation. Status updates on your application cannot be provided to you through this phone extension or email. For status updates, please log in to

For remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington.

To review the Integer U.S. Applicant Privacy Statement click here .

Welcome Thanks for your interest in working on our team! #J-18808-Ljbffr
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Design Quality Engineer II

Enniscorthy, Leinster BD (Becton, Dickinson and Company)

Posted 5 days ago

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Job Description

**Job Description Summary**
The Design Quality Engineer assures that new product designs and the processes for manufacturing them meet all local, corporate and divisional requirements with respect to safety and efficacy.
**Job Description**
**We are the makers of possible**
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
**Why join us?**
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
**Become a maker of possible with us!**
**Our vision for Quality at BD**
In our Quality team, we collaborate on a large scale, focusing on making sure everything is correct, effective and efficient to bring the highest-quality and most competitive products and services to our customers and their patients.
**About the role**
This role centers on ensuring quality and risk management throughout the lifecycle of new product development (NPD) projects. The individual represents quality interests within project teams, leading quality engineering tasks and risk management activities such as UFMEA, DFMEA, PFMEA, and related documentation. They are responsible for reviewing design compliance, conducting statistical analyses (e.g., DOE), and initiating corrective actions when necessary. The role also involves supporting biocompatibility testing aligned with ISO10993, participating in internal and supplier audits, and validating test methods and measurement systems like Gauge R&R.
Candidates for this position should possess a third-level qualification in engineering, science, or a technical field, along with a minimum of five years of experience in the medical device or pharmaceutical industries. A solid understanding of regulatory standards, including ISO 13485, ISO 14971, and related CFRs, is essential. Preferred skills include attention to detail, adaptability, strong problem-solving abilities, and excellent interpersonal skills.
The role requires someone who can manage multiple projects independently while collaborating effectively in team settings and meeting deadlines consistently.
**Main responsibilities will include:**
+ Represents quality interests and concerns on project teams.
+ Leads risk management activities and owns the Quality engineering activities for NPD projects.
+ Must be able to balance multiple projects and tasks, from product inception through product launch and maintenance.
+ Review design control compliance requirements for NPD projects and all design elements.
+ Is responsible for the development of the UFMEA & DFMEA, coordinating guidance from the other design sub-team members and supporting the development of the PFMEA.
+ Performs DOE's and other statistical analysis to support product and process optimisation or resolve causes of process variation. Initiate corrective actions as required.
+ Supports assessment of Biocompatibility testing required as per ISO10993 and company procedures.
+ Participates in internal audit and supplier audit programmes.
+ Risk management - U/DFMEA; Risk Analysis, Risk Management File and Gauge R&R and Test Method Validation.
**About you**
+ Third-level Engineer / Technical / Science Qualification
+ Minimum of 5 years in the medical device or pharmaceutical industry is desirable
+ Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR.
+ Attention to detail and adaptability
+ Dedication to excellence, flexibility
+ Problem-solving techniques with excellent organization skills
+ Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to target and deadlines
**Click on apply if this sounds like you!**
Becton, Dickinson and Company 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.
**To learn more about BD visit:** ** Skills
Optional Skills
.
**Primary Work Location**
IRL Wexford - Enniscorthy
**Additional Locations**
**Work Shift**
At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You ( .
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed.
The salary or hourly rate offered to a successful candidate is determined by their experience, education, and skills, as well as the labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location.
**Salary Range Information**
43,300.00 - 73,600.00 EUR Annual
Becton, Dickinson and Company 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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Design Quality Engineer II

Wexford, Leinster BD Medical

Posted 2 days ago

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Job Description

Job Description Summary The Design Quality Engineer assures that new product designs and the processes for manufacturing them meet all local, corporate and divisional requirements with respect to safety and efficacy. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Why join us? A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place. Become a maker of possible with us! Our vision for Quality at BD In our Quality team, we collaborate on a large scale, focusing on making sure everything is correct, effective and efficient to bring the highest-quality and most competitive products and services to our customers and their patients. About the role This role centers on ensuring quality and risk management throughout the lifecycle of new product development (NPD) projects. The individual represents quality interests within project teams, leading quality engineering tasks and risk management activities such as UFMEA, DFMEA, PFMEA, and related documentation. They are responsible for reviewing design compliance, conducting statistical analyses (e.g., DOE), and initiating corrective actions when necessary. The role also involves supporting biocompatibility testing aligned with ISO10993, participating in internal and supplier audits, and validating test methods and measurement systems like Gauge R&R. Candidates for this position should possess a third-level qualification in engineering, science, or a technical field, along with a minimum of five years of experience in the medical device or pharmaceutical industries. A solid understanding of regulatory standards, including ISO 13485, ISO 14971, and related CFRs, is essential. Preferred skills include attention to detail, adaptability, strong problem-solving abilities, and excellent interpersonal skills. The role requires someone who can manage multiple projects independently while collaborating effectively in team settings and meeting deadlines consistently. Main responsibilities will include: Represents quality interests and concerns on project teams. Leads risk management activities and owns the Quality engineering activities for NPD projects. Must be able to balance multiple projects and tasks, from product inception through product launch and maintenance. Review design control compliance requirements for NPD projects and all design elements. Is responsible for the development of the UFMEA & DFMEA, coordinating guidance from the other design sub-team members and supporting the development of the PFMEA. Performs DOE's and other statistical analysis to support product and process optimisation or resolve causes of process variation. Initiate corrective actions as required. Supports assessment of Biocompatibility testing required as per ISO10993 and company procedures. Participates in internal audit and supplier audit programmes. Risk management - U/DFMEA; Risk Analysis, Risk Management File and Gauge R&R and Test Method Validation. About you Third-level Engineer / Technical / Science Qualification Minimum of 5 years in the medical device or pharmaceutical industry is desirable Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR. Attention to detail and adaptability Dedication to excellence, flexibility Problem-solving techniques with excellent organization skills Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to target and deadlines Click on apply if this sounds like you! Becton, Dickinson and Company 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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Design quality engineer ii

Wexford, Leinster BD Medical

Posted today

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permanent
Job Description Summary The Design Quality Engineer assures that new product designs and the processes for manufacturing them meet all local, corporate and divisional requirements with respect to safety and efficacy. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Why join us? A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place. Become a maker of possible with us! Our vision for Quality at BD In our Quality team, we collaborate on a large scale, focusing on making sure everything is correct, effective and efficient to bring the highest-quality and most competitive products and services to our customers and their patients. About the role This role centers on ensuring quality and risk management throughout the lifecycle of new product development (NPD) projects. The individual represents quality interests within project teams, leading quality engineering tasks and risk management activities such as UFMEA, DFMEA, PFMEA, and related documentation. They are responsible for reviewing design compliance, conducting statistical analyses (e.g., DOE), and initiating corrective actions when necessary. The role also involves supporting biocompatibility testing aligned with ISO10993, participating in internal and supplier audits, and validating test methods and measurement systems like Gauge R&R. Candidates for this position should possess a third-level qualification in engineering, science, or a technical field, along with a minimum of five years of experience in the medical device or pharmaceutical industries. A solid understanding of regulatory standards, including ISO 13485, ISO 14971, and related CFRs, is essential. Preferred skills include attention to detail, adaptability, strong problem-solving abilities, and excellent interpersonal skills. The role requires someone who can manage multiple projects independently while collaborating effectively in team settings and meeting deadlines consistently. Main responsibilities will include: Represents quality interests and concerns on project teams. Leads risk management activities and owns the Quality engineering activities for NPD projects. Must be able to balance multiple projects and tasks, from product inception through product launch and maintenance. Review design control compliance requirements for NPD projects and all design elements. Is responsible for the development of the UFMEA & DFMEA, coordinating guidance from the other design sub-team members and supporting the development of the PFMEA. Performs DOE's and other statistical analysis to support product and process optimisation or resolve causes of process variation. Initiate corrective actions as required. Supports assessment of Biocompatibility testing required as per ISO10993 and company procedures. Participates in internal audit and supplier audit programmes. Risk management - U/DFMEA; Risk Analysis, Risk Management File and Gauge R&R and Test Method Validation. About you Third-level Engineer / Technical / Science Qualification Minimum of 5 years in the medical device or pharmaceutical industry is desirable Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR. Attention to detail and adaptability Dedication to excellence, flexibility Problem-solving techniques with excellent organization skills Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to target and deadlines Click on apply if this sounds like you! Becton, Dickinson and Company 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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Manager, Quality Control

Sligo, Connacht AbbVie

Posted 10 days ago

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Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
We are looking for a QC Manager to join our team on our Manorhamilton Road site in Sligo. The QC Lab Manager is integral to managing a team responsible for QC testing, ensuring adherence to product specifications, quality, and safety goals. This role involves overseeing laboratory operations, including analytical testing for API and OSD products, and coordinating with internal teams to meet testing schedules.
Responsibilities:
+ Manage a lab team performing QC testing, ensuring compliance with data integrity policies and regulatory requirements.
+ Conduct and supervise all aspects of API and OSD analytical testing.
+ Ensure timely sampling, inspection, and testing, coordinating with teams for schedules and priorities.
+ Participate in internal and external audits and address audit findings.
+ Prepare technical reports, lead investigations, and implement CAPAs.
+ Provide training and support to lab team to achieve daily and long-term goals.
+ Present technical data to stakeholders to facilitate prompt decision-making.
+ Report to the Senior QC Manager.
Qualifications
+ M.Sc./B.Sc. in Chemistry or a related discipline.
+ Minimum 4 years of experience in people management within a pharmaceutical lab setting.
+ Strong knowledge of QA/QC operations, analytical testing for API and OSD.
+ Excellent presentation and technical report writing skills.
+ Strong communication and interpersonal skills, with a commitment to quality and compliance.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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Manager Quality Control

Limerick, Munster Regeneron Ireland DAC

Posted today

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Within this role you will be responsible for the oversight of Quality Control support operations. As a Manager within Quality Control a typical day might include, but is not limited to, the following: Maintaining oversight of QC equipment lifecycle activities (including procurement, installation, qualification, maintenance, and decommissioning) Providing direction to Managers and staff that support the equipment Ensuring equipment qualification and maintenance programs are aligned with regulatory agencies requirements, qualified and available for QC laboratory usage Interacting with QC partner groups to establish internal requirements for equipment Leading QC equipment validation / qualification efforts through partnering and interaction with QA Validation and IT groups Managing oversight of the preventive and corrective maintenance monitoring program Managing oversight of the QC external laboratories activities and performance monitoring of external testing laboratories Supervising the issuance and approval of Quality agreements and SLAs with the contract labs Verifying that the site Manufacturing licence and global procedures reflect current contract lab utilization Identifying and calling out issues at contract laboratories to QC leadership Sourcing, co-ordinating and project management of GMP activities relating to new contract lab introduction Travel may be required in support of external contract laboratory testing activities Performing personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations Responsibility for equipment automation and associated projects This role might be for you if you: Possess strong communication and interpersonal skills Demonstrate logical troubleshooting and problem-solving skills Have a detailed understanding of equipment qualification and maintenance activities and industry compliance norms Have the ability to communicate effectively with multiple partners Enjoy working in a fast-paced environment Demonstrate a collaborative and team-orientated approach To be considered for this opportunity you should have a BA/BS in chemistry, biology or related field with 8+ years' proven experience preferably in the pharmaceutical or biotechnology industry, and previous supervisory or leadership experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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Quality Control Analyst

Waterford, Munster Cpl Resources

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We are currently seeking a QC Analyst with previous industry experience to join our client's site in Waterford on an initial 12 months contract. Key responsibilities: Provide analytical chemistry services and support to Site. Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases. In particular, close contact maintained with Quality Assurance Production, Engineering and Planners. Maintain, update and issue chemical methods, specifications and SOPs in compliance to pharmacopoeial and regulatory requirements. Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOPs and updates. Trend such results, record on COAs where required and complete OOSs investigations on a timely basis. Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means. Ensure all quality documentation and records are complete and current. Ensure QC laboratories meet current Good Laboratory Practice (cGLP) requirements. Ensure relevant procedures are correctly defined and followed. Ensure that critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ) where required. Audit and review chemistry test results on a daily basis and ensure compliance with cGLP. Checking/auditing laboratory notebooks and analytical reports Ensure compliance to cGMP at all times. Qualifications: Degree in Science (Chemistry or Biochemistry preferred). Postgraduate studies as appropriate to augment primary degree. 2-3 years experience working in a manufacturing environment ideally part of which would be in the pharmaceutical sector. Experience with some of the following tests: HPLC/UPLC, SDS-PAGE, Karl Fischer, HIAC, micro pipetting and ELISA. Skills: HPLC GMP Karl Fisher SDS-PAGE ELISA
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Senior Analyst, Laboratory Quality Control

Sligo, Connacht AbbVie

Posted 10 days ago

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Job Description

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
What you do, is what we need. Making a difference begins here. And takes all of us.
Welcome to AbbVie!
We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.
We are recruiting a Senior Laboratory Analyst to join our QC team on site in Manorhamilton Road, Sligo on a rotational shift pattern.
In your role as a Senior Laboratory Analyst, you will be responsible for providing an effective and analytical service to the plant ensuring that that products manufactured are tested to specification on time and plant quality and safety goals are met. This position will take responsibility for ensuring the timely testing and release of all raw materials, in-process, finished product, stability and contract testing. The senior analyst position is also responsible for ensuring all activities are carried out per schedule and records are maintained to appropriate requirements, they must also ensure that technical and systems excellence is maintained in the laboratory by ensuring own skills are maintained and implementing improved working practices in terms of efficiency, compliance and Right First Time.
What you will do:
+ Ensure Laboratory Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements.
+ Understand Regulations and business processes required to maintain Laboratory Data Integrity.
+ Ensure timely completion of all laboratory analysis assigned to shift.
+ Ensure that analysts working in the assigned cell or team are performing to the best of their ability, coaching and providing guidance where issues occur such as poor set-up or test execution performance.
+ Improve the overall efficiency and velocity within the assigned team.
+ Identify and implement improvements in analytical practices using 'Zero, Believe it, Achieve it'
+ Ensure that the agreed test schedule is adhered to and identifying recovery paths to bring test schedules back into alignment with plant requirements.
+ Identify weaknesses in laboratory performance and working with the laboratory Supervisors to rectify.
+ Support & initiate analytical OOS issues as they arise in a timely manner both through practical work and through Soltraqs.
+ Act as designee for the Laboratory Supervisor as assigned.
+ Ensure 6S excellence is maintained across the Laboratory.
+ Instill a quality culture of Zero, Believe it, Achieve it amongst the QC laboratory team
+ Ensure that all laboratory test equipment is utilised and maintained correctly.
+ Maintain up-to-date, complete and precise records of all tests performed.
+ Act as the primary point of contact for any analytical issues which arise.
+ Developing and changing of in-house laboratory procedures as appropriate.
Qualifications
What you will need:
+ 3rd level qualification in relevant Science discipline
+ Minimum 4 years' experience in Pharma industry
+ Strong knowledge of regulatory requirements
+ Must have strong knowledge of HPLC, GC,LCMS, GCMS, Automatic titration and Identification techniques.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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Senior Manager, Quality Control Laboratory

Westport, Connacht AbbVie

Posted 10 days ago

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Job Description

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
We are currently looking for a Senior Manager of Quality Control Laboratories to join our team in Westport on a 12-month fixed-term contract. The Senior Manager of Quality Control is responsible for strategy, planning, and management of laboratory operations, ensuring compliance with FDA, HPRA, and EPA safety standards and budgetary constraints. This role supports the QA site head in achieving operational goals.
Responsibilities:
+ Manage and motivate employees, ensuring capacity aligns with business needs.
+ Develop and deliver business plans, manage departmental budget, and handle new product implementation.
+ Represent the company in client and regulatory meetings, ensuring GMP compliance.
+ Organize cross-functional activities to improve lab efficiencies.
+ Coordinate meetings and manage documentation and compliance tools.
Qualifications
+ Proven track record in people and operations management within Pharma/Medical Devices/Food industry.
+ Qualification in Pharmaceutical Science.
+ Excellent conflict resolution, planning, and communication skills.
+ Ability to manage in regulated environments and adapt to changes.
+ Strong commitment to AbbVie's values and business ethics.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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Incoming Quality Control (IQA) Manager

Westport, Connacht AbbVie

Posted 10 days ago

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Job Description

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
AbbVie is seeking a dedicated Incoming Quality Control (IQA) Manager on our Westport site for a 12 month fixed term contract. This role is key to managing all IQA activities to support commercial, clinical, and development efforts at our site. The position involves ensuring comprehensive support across all business units and functions, providing guidance on QA/QC activities related to incoming inspection and release of packaging and manufacturing components, and maintaining the IQA department as a centre of excellence in quality, compliance, and efficiency.
Responsibilities
+ Establish and maintain strong relationships with the Associate Director, management, colleagues, and customers, effectively articulating quality requirements.
+ Motivate and manage employees through effective communication, ensuring daily handovers and performance review meetings align with company policy.
+ Maintain capacity and handle recruitment and management of staff, focusing on coaching and development of Quality technicians to support succession planning.
+ Assess and implement changes in response to new regulatory guidance, ensuring the success of compliance initiatives to enhance site quality programs.
+ Represent the company during Ministry of Health inspections and manage departmental budgets and headcount needs.
+ Oversee Non-conforming KPIs and maintain visibility on QMS records and compliance wire, staying updated on new inspection technologies and regulatory guidance.
+ Oversee the strategy, planning, and management of all incoming inspections, releases, and resolution of component queries in the IQA department.
+ Ensure equipment in all IQA areas is in good repair and maintain awareness of industry regulations and best practices.
+ Coordinate and schedule the IQA 1st shift, collaborating with the Associate Director to meet company goals and regulatory obligations.
Qualifications
+ Proven experience in quality control management, specifically within the pharmaceutical industry.
+ Strong technical, organisational, and people management skills with a track record of driving quality, compliance, and efficiency.
+ Expertise in IQA activities, including incoming inspection, release, retention, stock management, and file issuance.
+ Comprehensive knowledge of industry regulations and best practices, with experience supporting regulatory compliance and site audits.
+ Effective communication skills, with the ability to manage and motivate a team, articulate quality requirements, and interact with regulatory bodies.
+ Demonstrated ability to manage departmental budgets, assess regulatory changes, and develop strategic plans for quality enhancements
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
This advertiser has chosen not to accept applicants from your region.

Process Improvement Project Engineer

Dublin, Leinster Sanderson Recruitment (Ireland) Limited

Posted 2 days ago

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Process Improvement Project Engineer Job Purpose: Reporting to the CEO you will be designing, developing, & optimising manufacturing processes to unlock capacity, eliminate bottlenecks, & enhance operational efficiency. You will drive scalable growth while maintaining the highest standards of product quality, safety, & compliance, identifying barriers to growth, recommending improvements, & leading strategic process optimisation initiatives. Key Responsibilities you will: - Process Documentation & Barrier Identification Lead the effort to document barriers to growth & operational inefficiencies within current production lines. Develop detailed process maps & identify areas for improvement, collaborating with cross-functional teams to implement solutions. Recommend future capital investment needs based on identified process constraints & opportunities for growth. Process Design To work closely with the R&D & Engineering teams to design sustainable aligned with future business needs. Lead all other initiatives to grow manuf. capability inc. the design & dev. of new manuf. facilities to support business scalability. Process Optimisation & Capacity Mgt. Conduct in-depth analysis of current production processes to identify capacity constraints, inefficiencies, across all technologies. Develop & implement strategies to resolve capacity issues, improve throughput, reduce batch fails & maximise yields & production output. Work closely with the operations team to optimize resource allocation & production scheduling & reduce downtime Lead initiatives to enhance plant capacity utilisation through process re-engineering & Lean Manufacturing principles. Continuous Improvement Promote & drive the company's continuous improvement programme using Lean/Six Sigma methodologies & principles. Design & implement process improvements that enhance product quality, reduce waste, & optimise yield. Monitor & report on (KPIs) to track the impact of improvements & ensure alignment with company goals Project Mgt. Lead process improvement projects from initiation through to implementation, ensuring projects are completed on time, within budget, & with minimal disruption to production. Develop & manage project timelines, resources, & budgets, ensuring effective execution of process optimisation initiatives. Collaboration & Stakeholder Mgt. Collaborate with operations, engineering, maintenance, S&T & R&D teams to ensure alignment in achieving operational goals & implementing process improvements. Effectively communicate process changes, new methodologies, & best practices effectively to all levels of staff. Work with the Senior Leadership Team to align process improvement strategies with broader business objectives. Training & Development - support the training & dev of operations staff on new processes, equipment, & operational procedures. CapEx - Lead all other initiatives to exp&/unlock manuf. capability inc. the location & design of a new manufacturing facility. Demonstrate financial discipline & compliance to overall Capex policy. Skills & Qualifications / Experience you will bring: - 3-5 years in process Eng or Operations management within manufacturing ideally in the food industry. BSc/BA in a Business project management or engineering related discipline. Exp. with automation tech, digital manufacturing, data-driven process optimisation Strong operational, commercial awareness, sound judgment & decision-making capability. Expertise in process mapping, root cause analysis, & process reengineering. In-depth knowledge of statutory & regulatory requirements of Food Safety, Customer Codes of Practice, H&S, & Env. Compliance. Can implement Lean Manuf. principles & CI methodologies. Strong problem-solving ability for mech & process-related challenges, addressing root causes. Exceptional stakeholder mgt. skills, inc. exp. work with employees, customers, auditors, & vendors/contractors. Proven negotiation & influencing skills in complex operational environments Excellent communication skills (both verbal & written) sharing technical concepts easily . Collating, analysing, & presenting data to support strategic decision-making. Challenge status quo & drive meaningful change in a constructive & professional manner. Strong business acumen with a proactive & strategic mindset. Enthusiastic, energetic, & optimistic with a can-do attitude. Working 4 days on site and 1 from home. The Benefits include: Commensurate salary negotiable Laptop, phone, P-card; Daytime role (M to F) 08:30 - 17:30 and at least four days on site. Skills: project engineering NPI food production process improvement
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