46 Quality Assurance jobs in Ireland

Job Summary Nua Healthcare Services (Nua) is one of Ireland's leading Private Healthcare Providers, specialising in Residential and Supported Living Services, to both Children and Adults with a range of complex support needs. We are seeking applications from energetic and enthusiastic individuals to join our team for the above positions. The successful candidate will be afforded all necessary training and development in line with the role. Candidates must be highly motivated and creative, with a passion for engaging with Service Users on a daily basis. Candidates will contribute to enriching the lives of our Service Users. Job Objectives We are seeking a dedicated and experienced Quality Assurance Officer to join our dynamic team at Nua Healthcare. We have several positions available, within the areas of Kildare, Meath and Dublin The post holder will ensure compliance, both operational and legislative across all areas of the business along with conducting audits across all areas of the business. Submit reports, agree corrective actions, and support Teams to action any approved recommendations regarding business activities. This will include the following on a day-to-day basis: Live our Mission, Vision and Values. Support the development and implementation of the Internal Audit department and its policies and procedures. Support the design of audit programs and execute audits to verify compliance with legislation, regulation, standards and company policies and procedures. Communicate Audit findings to key Management and follow up on audit issues. Analyzing large amounts of data. Implementation of any recommendations approved. Undertake continuous improvement programs in conjunction with Operations and Clinical Services departments. Develop and maintain an excellent knowledge of all business activities. Develop and maintain excellent knowledge of accepted professional standards such as HIQA. standards, HSE, HSA and all relevant legislation regarding our business. Assist Centre Management regarding compiling and presenting reports as required (Reg 23 Six Month Visit & Annual Report). Maintain strict confidentiality in relation to staff and service users. Please note: This role requires travel nationwide Skills Requirement Qualifications: A Third Level Qualification in Healthcare / Social Studies (or suitable equivalent relevant qualification). Knowledge: Knowledge of standards and legislation relevant to the area. Some (demonstrable) previous knowledge of: Standards and legislation relevant to the health and social care sector. Quality Frameworks / Quality Improvement Tools. Health & Safety Management and associated legislation. Experience: Demonstrable previous experience in a similar role. Experience of / with people with additional and/or complex needs. Skills: High standard of IT literacy. Excellent problem solving and decision-making skills under pressure, ability to work on your own initiative. Excellent organisational skills / self-motivated / self-starter. Excellent verbal, written communication, and IT skills. Full Clean Drivers Licence Benefits Company Pension Company Vehicle Continuous Professional Development Fantastic development & career opportunities Life Assurance/Death-in-Service Paid Maternity/Paternity Leave Education Assistance Employee Assistance Programme (EAP) Bike to work Scheme. Refer/Retain a friend bonus. Discounts with Retailers - Nationwide Attachment(s): Quality Assurance- Job To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Apply button below to Login/Register.

Functions The incumbent ensures timely and effective completion of the Quality Systems core functions in accordance with schedules and MMD policies, procedures and guidelines, including; Sub System Ownership: Complete sub system ownership responsibilities as per the site System Ownership list. Quality SME for Process, Cleaning, Water, Equipment To provide leadership, through knowledge and skill regarding the validation standards required for a Drug Substance and Drug Product (SDI & OSD) pharmaceutical facility. Includes participating in and supporting the site PVC (Process Validation Committee), WVC (Water Validation Committee), CVG (Cleaning Validation Group),) and Equipment Qualification Validation Committee (EQVC). Approval of all validation documentation and ensuring compliance to MMD policies, procedures and guidelines. Ensures that validation status is maintained following changes/modifications. Supports the implementation of site or capital projects by defining validation requirements and providing technical assistance and support as a member of the project teams. Develops Validation Summary Reports and assist in developing overall Quality plans for major projects. Works with other areas in MMD and industry to predict future trends in validation and to determine best practice. SAP Quality Process Steward Quality SME for Change Control. Principle Quality contact for all site change requests (with impact on processing) Provide Quality and change analyst review for all change requests through all the stages of the change control process ensuring compliance with MMD and site policies, procedures and guidelines. Principle Quality contact for all Quality assessment of material control strategies associated with change requests for processing and analytical changes. Laboratory QA oversight Support and approve the systems supporting laboratory functions, instrumentation and GLIMS. Provide Quality oversight and approval for laboratory incidents / investigations and documentation. Stability oversight: Review and approval of stability reports (Intermediate and API stability data and reports are reviewed for accuracy and to support OOS and investigations as appropriate). Microbiology Point of Contact. Knowledge of microbial requirements in the pharmaceutical industry, to liaise with site Microbiologist for all microbial issues eg water, utilities, environment, excipient or product and as necessary. Quality Agreement System Management Manage the site inventory of Quality Agreements to ensure Quality Agreements are raised for all required relationships. Interact and communicate with SD&PM, relevant stakeholders and external parties to ensure appropriate Quality Agreements are current, approved, on file and retrievable. Annual Review System Management Manage the system ensuring that Annual Reviews (AR/APR/PQR) for products and systems incl automation, are completed to meet the Annual Review schedule. Creation, review and approval of Site Quality documentation including; Site Master File, Validation Master Plan, policies or procedures. Quality Oversight of site application User Access Reviews Approval of all designated user access reviews, ensuring compliance with site and MMD policies and procedures. Quality Council Manage the annual quality council schedule. Manage the monthly quality council agenda, minutes and action follow up. Supplier Change Evaluations Quality Role Review and approve Supplier Change Evaluation documentation. Complete/Approve MDS updates post SCE approval Approve Supplier Transparency update change requests post SCE approval Generate quality / technical agreements with suppliers as appropriate. Supplier and Customer complaints Participate in the investigation and review of any internal / external customer complaints in accordance with agreed lead-times. Participate in the investigation and review of any supplier complaints in accordance with agreed lead-times. Filing & Licence maintenance and Regulatory Requests follow ups Review and ongoing maintenance of site licences. Provide site documentation to support product filings in accordance with CMC requests. QA Regulatory Data: Review and verify MSD documentation that may be used for submission to Pharm CMC or other requester(s) for regulatory submissions/filings. Assure the accuracy and integrity of all data and information through a timely review program. Returned Goods Manage the segregation and disposition of all returned goods. Audit program Support the internal GMP walk-down and scheduled audits program. Support hosting of site Regulatory Inspections. Special Features: The incumbent operates as part of self-directed team in carrying out day to day functions and assigning priorities. The incumbent monitors appropriate performance metrics to ensure that the CoE delivers on all responsibilities in line with business needs. On assignment, the incumbent participates in departmental initiatives on improved compliance, and quality systems and participates in cross functional interdepartmental teams. The incumbent must be assertive with excellent communication skills, who can develop cross functional relationships at and network outside the plant. The incumbent promotes GMP awareness at the site. Qualification Minimum of Degree or post-graduate qualification in Science, Pharmacy or Engineering field. Skills: IT Quality Assurance SAP change control CAPA Trackwise QMS

MAIN PURPOSE OF THE JOB: To be involved in all aspects of Quality relating to the Quality and Operations departments, working in compliance with current GMP standards and EU regulations. Involvement in the Research & Development sphere of the company as required. EDUCATION AND EXPERIENCE: BSc in Science or related field Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas. Thorough understanding of quality systems and cGMP's. MAIN DUTIES OF THE JOB Compliance Ensure through monitoring, that the Production, Quality Control, Supply Chain and Engineering departments and procedures are maintained in accordance with current good manufacturing practice. Support Role Provide QA support and knowledge to the Production, Quality Control, Supply Chain and Engineering departments. Assess and advise on deviations and other issues as appropriate within the relevant departments. Inspections of cleandown, as required, Performance of line clearance as required. Documentation Review of batch records in preparation for QP disposition, while following the companys procedures in respect to data governance and integrity. Initiate updates to Standard Operating Procedures as required. Issuance of batch documents. Issuance of other controlled documents. General Assist in the preparation of customer and regulatory audits. Performance of self-inspections and preparation of internal audit reports. Maintenance of the supplier qualification system. Involvement in vendor complaint investigation. Involvement in customer complaint investigation and other customer queries. Involvement in deviation investigations. Involvement in change control system. Involvement in projects from a Quality Assurance prospective. Involvement in validations from a Quality Assurance prospective. Ownership of the archiving system. Maintenance of the deviation and internal audit spreadsheets. This is a guideline and is not intended to be all encompassing. RELATIONSHIP TO OTHER FUNCTIONS/ROLES: Liaison with Laboratory, Production, Supply Chain, and Engineering departments and external organisations as required.

Quality Assurance Administrator We are seeking a detail-oriented and proactive Quality Assurance Administrator to support our clients Quality Assurance team. You will be ensuring compliance across the Quality Management System (QMS) in accordance with ISO 13485, IVDR (EU 2017/746), and other applicable regulatory standards. This role is critical in ensuring the integrity of documentation, audit readiness, and continuous improvement within our medical device operations. For You: Full-time permanent role. 35k DOE Located in Wicklow with parking. Join a collaborative and supportive team. Competitive benefit package. Primary Responsibilities: Oversee the upkeep and revision of Quality Management System (QMS) documentation, including standard operating procedures, work instructions, and associated records. Contribute to the development and ongoing support of processes aligned with IVDR requirements. Organise and manage internal and external audits, including planning, documentation handling, and follow-up on corrective actions. Provide support for CAPA activities, handling non-conformances, and overseeing change control initiatives. Track and report on training compliance across all relevant departments. Assist with risk management efforts in line with ISO 14971 standards. Ensure proper implementation of document control protocols and secure record archiving. Work collaboratively with cross-functional teams to maintain compliance with quality and regulatory standards. Generate and present quality performance indicators and reports for leadership review. Key Requirements: Strong administrative capabilities. Ideally, 2+ years of experience in a quality or regulatory capacity within the IVD or medical device sector. Working knowledge of ISO 13485, IVDR, and ISO 14971 standards. Excellent organisational and verbal/written communication skills. Skilled in using document control platforms and Microsoft Office applications. High attention to detail and ability to balance multiple tasks effectively. Familiarity with electronic QMS tools (e.g., MasterControl, Veeva, Greenlight Guru). Understanding of MDR and FDA 21 CFR Part 820 is advantageous. Prior experience supporting audits (internal, supplier, or notified body). For more information, please apply through the link provided for the attention of Nikki Moloney or call Osborne Recruitment on . If you are interested in finding out more about the above role and would like to be considered for this or other suitable roles that we may have available for your skill set please attach your CV via the link provided. Please submit your updated CV in Word Format. If you are living in Ireland and hold a VALID WORK PERMIT, we would love to hear from you, if however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search. Osborne are proud to be an Equal Opportunity Employer. #INDNMOLONEY #INDOSB1

**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 114,000 colleagues serve people in more than 160 countries.
**Abbott in Ireland**
Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.
**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 OF THE JOB**
Provide Process/Quality Engineering support to manufacturing and projects 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
**MAJOR RESPONSIBILITIES**
+ Identifies manufacturing process defects (scrap, non-conforming material, customer complaints) by dispositioning non-conformingmaterial, 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.
+ 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 (FNMA) in conjunction with other product development team members. May be responsible for providing input to risk analyses and Failure Mode Effect Analysis' (FMEAs).
+ 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.
+ 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.
+ 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.
+ Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
+ Participates in corrective and preventive action activity.
+ Participates in Field Discrepancy Notification (FDN) investigations.
**EDUCATION & COMPETENCIES**
+ National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline. 2+ years of related work experience, or an equivalentcombination of education and work experience.
+ 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.
+ 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.
+ 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.
+ Plans, organises, and prioritises own daily work routine to meet established schedule.
+ 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.
+ Works with general supervision. Trains new Quality Engineers. 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.
Connect with us at and on LinkedIn , Facebook , Instagram , X and YouTube .
**REFER TO THE SITE SAFETY STAT** **E** **MENT (SHE038447) FOR YOUR SA** **F** **ETY, HEALTH AND WELFARE AT WORK RESPONSIBILITIES**
**Abbott Ireland is an Equal Opportunities Employer**
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

**Abbott in Ireland**
Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations, and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
**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 OF THE JOB**
Provide Process/Quality Engineering support to manufacturing and projects 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. Will be the liaison to cross function departments (for example Research and Development, Operations and other Quality Functions). Must be able to analyze data and assist in interpreting the data. Develop and implement investigation process improvements.
**MAJOR RESPONSIBILITIES**
+ Responsible for compliance with applicable corporate and divisional policies and procedures. Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort.
+ Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project.
+ Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.
+ Communicates project status by preparing standard status reports, and by participating in departmental and customer project status update meetings.
+ Resolves project issues by working with team members, project customers, and others as appropriate.
+ Translates business strategy into meaningful objectives and day-to-day activities required to accomplish them.
+ Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for querying and bounding data to support implementation of complex and documenting release criteria.
+ Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. May be responsible for creating risk analyses and Failure Mode Effect Analysis (FMEA).
**EDUCATION & COMPETENCIES**
+ National Framework of Qualifications level 7 qualification in a relevant discipline and 4+years of related work experience, or an equivalent combination of education and work experience.
+ Wide application of technical principles, practices and procedures. Strong understanding of business unit function and cross group dependencies/relationships. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
+ Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact.
+ Establishes and cultivates an extensive network of support to facilitate completion of assignments. Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. May interact with vendors.
+ Plans and organises non-routine tasks with approval. Initiates or maintains work schedule. Establishes priorities of work assignments. (Decision Making/Impact) Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
+ Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
+ Will provide work direction and guidance to exempt and/or skilled nonexempt levels of employees will be asked to evaluate performance of and assist in career development planning for subordinates.
**REFER TO THE SITE SAFETY STAT** **E** **MENT (SHE038447) FOR YOUR SA** **F** **ETY, HEALTH AND WELFARE AT WORK RESPONSIBILITIES**
**Abbott Ireland is an Equal Opportunities Employer**
Connect with us at , on LinkedIn at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
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

Who We Are Looking For State Street is looking for QA Automation Engineer with 5+ years of experience for the Middle Office team. The ideal candidate should have test automation experience of complex applications. This is someone who has demonstrated success working closely with business units and the software development team. The candidate has excellent problem-solving skills, is creative and self-motivated to deliver on mission critical projects with tight timelines and competing priorities. What You Will Be Responsible For As QA Automation Tester you will Work with business unit and Software Development team to identify testing requirements Develop and maintain the test strategy, testing scenarios, test automation processes in alignment with the project and the organization's standards (i.e., governance, processes and tools) Create test scenarios and implement automated functional test cases that will serve as acceptance test criteria for enhancements and new applications Work with the support group to reproduce production problems and identify gaps in the regression test suite Find ways to enhance the testing process with new tools, strategies or techniques Responsible for designing, developing, and implementing the long-term automation strategy and framework to increase the percentage of test automation coverage and reduce test timelines Run test suits and analyze results Defect management oversight by providing timely defect reporting, safekeeping and tracking through defect-life-cycle Collect and effectively communicate test execution metrics Participates in daily stand-up, iteration planning, product demos and retrospective meetings Education & Preferred Qualifications/Skills B.S. in Computer Science or related field 5+ years of QA testing experience in automated testing, code repository and deployment tools such as Selenium, Cucumber, TestNG, Silk test, SVN, Gradle, Jenkins, etc Two or more years of full-time experience in an iterative development environment using an iterative Agile-like methodology, with experience of delivering working software to production through the entire lifecycle Expert knowledge of SQL and relational databases Knowledge of XML, VBScript and Macros is an added advantage Ability to quickly troubleshoot and diagnose issues within the quality assurance environment and communicate that knowledge to a varied audience of technical and non-technical stakeholders Experience testing both client-server, and web-based applications through one or more full life cycles of an application Knowledge of financial securities and trading principles Experience leading a team, including assigning project priorities, communicating QA status to other managers and mentoring less experienced associates Team oriented attitude Strong organizational skills and attention to detail Excellent verbal and written communication skills About State Street What we do. State Street is one of the largest custodian banks, asset managers and asset intelligence companies in the world. From technology to product innovation, we're making our mark on the financial services industry. For more than two centuries, we've been helping our clients safeguard and steward the investments of millions of people. We provide investment servicing, data & analytics, investment research & trading and investment management to institutional clients. Work, Live and Grow. We make all efforts to create a great work environment. Our benefits packages are competitive and comprehensive. Details vary by location, but you may expect generous medical care, insurance and savings plans, among other perks. You'll have access to flexible Work Programs to help you match your needs. And our wealth of development programs and educational support will help you reach your full potential. Inclusion, Diversity and Social Responsibility. We truly believe our employees' diverse backgrounds, experiences and perspectives are a powerful contributor to creating an inclusive environment where everyone can thrive and reach their maximum potential while adding value to both our organization and our clients. We warmly welcome candidates of diverse origin, background, ability, age, sexual orientation, gender identity and personality. Another fundamental value at State Street is active engagement with our communities around the world, both as a partner and a leader. You will have tools to help balance your professional and personal life, paid volunteer days, matching gift programs and access to employee networks that help you stay connected to what matters to you. State Street is an equal opportunity and affirmative action employer. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.

Overview The primary responsibility of Manager, Quality Assurance, Cook Medical Europe Ltd. (CMEU), is to ensure that the Quality Management System (QMS) for CMEU meets Cook Group and relevant external regulatory requirements. This includes ensuring that the QMS is implemented, maintained and understood by all employees within CMEU. Reporting to: Director, Quality Assurance Responsibilities Ensure that the QMS for CMEU meets all relevant regulations including ISO/EEC, Medical Device Directive, FDA 21 CFR Part 820 Quality System Regulations, Regulation (EU) 2017/745 (EU MDR), FDA 21 CFR Part 11 Electronic Records/Electronic Signatures and FDA 21 CFR. Ensure compliance of the QMS for CMEU with global QA policies, procedures and direction. Management representative for CMEU. Ensure that processes needed for the CMEU QMS are documented. Report to top management on the effectiveness of the QMS and any need for improvement. Ensure the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organization. Manage the team with overall responsibility for ensuring that the QMS for CMEU is implemented, maintained and understood by all employees within CMEU, whilst meeting all relevant external regulatory requirements. Manage, as appropriate for this team, activities such as hiring, promotions, transfers, and training and development, including providing regular direction, feedback and corrective action on performance, preparing and delivering annual performance and salary reviews for directs reports. Develop direct reports and wider team through ongoing coaching and mentoring for continued employee growth and team succession planning. Maintain overall responsibility for the performance of the CMEU QMS through management review and internal audits; proactively communicating the effectiveness of the QMS and any need for improvement to all relevant stakeholders and executive management and taking action to correct any identified deficiencies in a timely manner. Maintain overall responsibility for the CAPA and NCR systems for CMEU, issuing corrective and preventive actions in relation to non-conformities as required, and monitor effectiveness of same. Maintain overall responsibility for the customer complaints process, ensuring that customer complaints are dealt with appropriately by the Customer Relations team and transferred to the relevant manufacturer within agreed timelines. Assist with field safety corrective actions within Europe, communicating with customers and Competent Authorities. Responsible for the generation of Management Review reports. Preparation, execution and analysis of related quality documentation. Work closely with stakeholders in CMEU to ensure quality metrics are met or exceeded facilitating / leading interdepartmental meetings as appropriate to resolve any issues. Monitor trends and analyse key Quality Metrics. Maintain overall responsibility for managing internal and external regulatory audits, perform internal and external quality audits as required and perform Supplier Audits where necessary. Manage quality costs and ensure a full understanding of departmental expenditure and budget. Work collaboratively with the relevant business stakeholders, vendors and functional groups on new business opportunities, projects and improvement initiatives. QA representative on any relevant projects / meetings / events within CMEU. Maintain strong links with the Quality Assurance community within Cook Medical. Contribute and work as part of the local management team to help create a synergistic and cohesive environment. Act as a Continuous Improvement advocate, working with the Continuous Improvement Team, driving Continuous Improvement philosophy and practices Delegate for Global Director, Quality Assurance, Customer Support and Distribution for Quality related processes. Delegates for this position are Coordinator Customer Relations, EMEA, and Quality Assurance Engineer. Ensure adherence to pertinent Quality and Regulatory requirements and to departmental policies, practices and procedures. Ensure that Cook Medical's Code of Conduct is considered in all business matters carried out on Cook Medical's behalf. Qualifications 7-plus years of applicable experience in a quality environment Minimum of 3 years' management experience leading Quality professionals. Bachelor's degree or equivalent in Quality, Science or Engineering. Knowledge and experience of ISO13485, MDD, EUMDR 2017/745 , and other applicable regulations to EMEA region desirable. Knowledge and experience of FDA QSR including 21 CFR Part 820 and CFR Part 11, 93/42/EEC, Medical Device Directive, GMP, and International Quality Requirements, desirable. Knowledge and experience of all aspects of Quality Assurance, Quality Engineering and Regulatory Affairs. Excellent communication and inter-personal skills. Excellent analytical, problem solving and organisational skills Excellent collaboration and interpersonal skills, with a track record of developing strong working relationships globally and with business partners. Ability to work constructively in a matrix-management structure. Willingness and availability to travel on company business. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.

Job title:Design Quality Assurance Engineer Location: Ballybrit Upper Industrial Estate, Galway Benefits:Top salary, Pension, healthcare, yearly bonus, 4 day week. Client: My client are the global expert in the design, development, and manufacturing of complex medical devices and component technologies Role overview: As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected. As a Design Quality Assurance Engineer you will be responsible for assuring product quality, safety and effectiveness. Responsibilities: As a lead Quality Engineer on projects, directly contributing and/or providing guidance to others to establish quality documentation. Providing detailed planning for pilot production and scale-up plans in New Product Introduction programs. Ensuring project teams are utilizing Medical Quality Systems and appropriate regulations and industry standards throughout the product development process. Conducting risk assessments of the design to determine ability to function as intended. Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and vendor audits, product release, document control, design control process and design history files (DHF), device master records, etc. Interacting with customer and supplier companies in a professional manner; proactively communicating with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required. Intervening and contributing to successful resolution of technical issues when they arise. Ensuring that all work satisfies the requirements of the company's Quality Management System. Skills and Qualifications: Minimum Bachelor's degree in Engineering or related field. 3 years of medical device design and development/quality assurance experience is required. Managing customer relationships and responses in aa timely manner. Ability to interact with client companies in a professional manner. Demonstrated ability to lead product verification & validation activities Experience working with operations to develop strong manufacturing process instructions is desired. Familiarity with FDA QSRs, medical device regulations and ISO 13485 Does this sound like your next career move? For more info forward your application or contact me on OR Benefits: Bonus, pension, healthcare, 4 day week