Quality Assurance Specialist 2

18 hours ago


Limerick, Ireland Cook Ireland Ltd Full time

Overview The primary responsibility of this role is to provide Quality Assurance support as required within Cook Medical Europe Ltd. (CMEU) This includes completing internal audits and maintaining the internal audit system; providing support to software validation, change requests, non-conformance issues and the Company's corrective and preventive action program; and assisting in the implementation and improvement of all aspects of the quality management system (QMS) Reporting to: Senior Manager, Quality Assurance Responsibilities Maintain an active oversight of the CMEU QMS to ensure it is fit for purpose and ensures compliance with procedures, requirements and best practice. Maintain the internal audit system in CMEU, acting as the Quality Internal Auditor with a team of Internal Auditors. Conduct in-depth internal audits of all aspects of the QMS against the relevant regulations, and work collaboratively with relevant stakeholders to achieve zero non-conformances within CMEU. Maintain a detailed and up to date knowledge of medical device regulations, guidance and requirements relevant to Quality Assurance. Organise and manage site preparation and manage audit back rooms for Regulatory and Corporate Audits. Provide Quality Assurance support to all areas of the QMS, ensuring compliance is maintained at all times. Identify, lead and drive QA process improvement initiative as appropriate. Prepare, implement and analyse key Quality Systems related documentation. Maintain and support to the Corrective and Preventive Action (CAPA) program. Maintain and support the Non-conformance program. Delegate for the Manager, Quality Assurance, CMEU. Provide training on the CMEU Quality Manual and other key Quality Systems procedures as required. Provide inputs to KPI's and Management Review. Prepare Management Review presentations as appropriate. Provide meaningful Quality Assurance measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications Third Level qualification in Quality, Science, Engineering or other relevant technical discipline. Knowledge and experience (min 4 years of working with ISO13485, ISO14971, the Medical Device Directive , the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, Regulation (EU) 2017/745 (EU MDR) and other Regulations applicable to EMEA regions, ideally gained in the medical device industry, desirable. Qualified and experienced Lead Auditor, preferably within the medical device industry. Good working knowledge of Microsoft Office, desirable. Strong interpersonal skills with the proven ability to communicate effectively at all organisational levels. Demonstrable ability to challenge / influence thinking / opinion / actions with the aim of ensuring CMEU QMS is adhered to. High attention to detail. Excellent organisational skills, with the ability to manage own time effectively. High self-motivation, with a proactive, solution driven approach to problem-solving. 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.



  • Limerick, Ireland Northern Trust Full time

    About Northern Trust: Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring...


  • Limerick, Ireland Cook Ireland Ltd Full time

    Overview The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates,...

  • Quality Engineer 2

    3 hours ago


    Limerick, Ireland Cook Ireland Ltd Full time

    Overview The primary function of this role is to provide Quality Engineering support to Production, Quality Control, Purchasing, Facilities, IT, Regulatory, Analytical Lab, Research and Development and Engineering Sustaining teams This includes, but is not limited to, providing support to process validation, change requests, non-conforming product issues,...


  • Limerick, Ireland Cook Medical Full time

    Overview The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates,...


  • Limerick, Ireland Cook Medical Full time

    Overview The primary function of this role is to provide Quality Engineering support to Production, Quality Control, Purchasing, Facilities, IT, Regulatory, Analytical Lab, Research and Development and Engineering Sustaining teams This includes, but is not limited to, providing support to process validation, change requests, non-conforming product issues,...


  • Limerick, Ireland Regeneron Ireland DAC Full time

    The Quality System Specialist participates in maintaining site compliance of operations in accordance with mandated regulatory requirements and site expectations. The Quality Systems Specialist provides oversight of the Quality Management System (QMS) implementation and use. This position may also support global elements of the QMS and lead or participate in...


  • Limerick, Ireland Regeneron Ireland DAC Full time

    The Global Procurement, Supplier Quality Compliance Specialist will be responsible for supporting cGMP compliance aspects of Regeneron's procurement operations. The major activities include but are not limited to the following: working with team members and our Approved Supplier List (ASL), deviation investigations, CAPAs, supplier audit closures and...

  • Chemist 2

    18 hours ago


    Limerick, Ireland Cook Ireland Ltd Full time

    Overview The primary function of this position is to lead and/or participate in projects focused on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices , specifically providing oversight in method development and validation, compendial method verification and transfer , specification/acceptance...


  • Limerick, Ireland Milford Care Centre Full time

    Milford Care Centre, Limerick Serving the People of the Mid-West (Under the auspices of Little Company of Mary) Milford Care Centre, working in partnership with the Health Service Executive, provides a comprehensive range of Specialist Palliative Care Services and Services for Older People throughout Counties Clare, Limerick and North Tipperary (Mid-West...


  • Limerick, Ireland Cook Ireland Ltd Full time

    Overview The Manufacturing Engineer 2 (Test Method Validation) Reporting to: Manager, Manufacturing Engineering Responsibilities Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards. Validate and implement medical device manufacturing processes as assigned. Identify equipment/fixture installation qualification...


  • Limerick, Ireland Regeneron Ireland DAC Full time

    The Principal GMP Data Governance Specialist plays a pivotal part in ensuring that Regeneron's Data Governance (DG) systems and practices meet the highest standards of regulatory and industry compliance. You will beresponsible for providing specialised knowledge and expertise in the design of (DG) frameworks, policies and procedures that are aligned with...


  • Limerick, Ireland Cook Medical Full time

    Overview The Manufacturing Engineer 2 (Test Method Validation) Reporting to: Manager, Manufacturing Engineering Responsibilities Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards. Validate and implement medical device manufacturing processes as assigned. Identify equipment/fixture installation qualification...


  • Limerick, Ireland Cook Medical Full time

    Overview The Manufacturing Engineer 2 (Test Method Validation) performs and documents validations of medical device manufacturing processes. Reporting to: Manager, Manufacturing Engineering Responsibilities Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards. Validate and implement medical device manufacturing...


  • Limerick, Ireland Cook Ireland Ltd Full time

    Overview The primary responsibility of this position is to support / lead on the design, development and taking to market of medical devices for Cook Medical. Reporting to: Team Lead, Research and Development / Manager, Research and Development Responsibilities Perform Duties of Research & Development Engineer 2: Design development, prototyping, test method...


  • Limerick, Ireland Zenovo Limited Full time

    Position: Embedded Software Engineer ( 2 years+ experience) Location: Limerick ( required onsite 3-4 days per week) Zenovo Ireland are supporting a technology company with offices in Limerick, we are looking to recruit a permanent Embedded Software Engineer with 2+ years commercial experience. Our partner produce innovative products used in the retail, O&G,...


  • Limerick, Ireland Edwards Lifescience Ireland Ltd Full time

    Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients' lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us...


  • Limerick, Ireland Regeneron Ireland DAC Full time

    This is a leadership role providing Quality and Compliance oversight of site operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. As a Associate Manager Quality...


  • Limerick, Ireland 360 Search Full time

    360 Search are delighted to recruiting for a Group Pensions Specialist opportunity with a highly regarded Financial Service broker based in the Mid-West. Our client is hugely experienced in all areas of Personal Financial Planning, as well as having the necessary qualifications required to provide advice to all new and existing clients. Their aim is...


  • Limerick, Ireland Cregg Recruitment Full time

    CREGG is delighted to be recruiting a Junior Sales Specialist to join an industry leaders in providing high end design solutions in the Architectural, Engineering and Construction sectors. This is a permanent, hybrid opportunity working from their offices in Limerick. In this role you will be working closely with the sales and technical teams delivering on...


  • Limerick, Ireland BMS Recruitment Full time

    Excellent field-based training role for a qualified healthcare professional Training and support role working within Community Nursing, Care Homes, and Hospitals. Privately-owned company with excellent products and service Emphasis on strong teamwork and collaboration THE COMPANY: They provide a well-respected, quality range of products that are used for a...