Senior Design Assurance Engineer
SIGMAR RECRUITMENT
LIMERICK
Senior Design Quality Assurance Engineer. A growing medical device and technology company providing devices, instruments and reagents within the MedTech sector. This current position based in Limerick is within a brand-new site for this global multinational and will be part of several NPD and NPI projects while also being a key part of the overall growth of the company. You will report into the Quality Manager for the research centre but act as lead for Design Assurance activities. Ideally this person will come from a Quality Assurance background with exposure to Product Design, Development or Validation. Responsibilities: Work on technology transfers into the large research centre, leading design control, design assurance and design development projects and activities. Act as an Subject Matter Expert with developing and managing the QMS onsite to support design activities. Provide guidance and lead the team for design controls according to 21CFR 820 regulations during new product development. Review product development documentation and product development tests, completing risk analysis. Ensure total compliance to regulatory and notified body requirements and standards. Manage the risk management plan and complete DFMEA activities. Review and approval of Verification and Validation plans, protocols and reports. Complete IQ and OQ approvals and act as liaison for product investigations. Requirements: Must have 5 years or more experience within the medical device industry or an industry that is similarly highly regulated. Ideally ISO13485 or FDA exposure. Honours degree in STEM subject. To apply for this position please contact James Porter at Sigmar RecruitmentT: +353 91 455305E: jporter@sigmar.ie. All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.
1406 days ago