Design Assurance Engineer – Start-up
- Work within the QMS and Quality Policy in line with the MDD 93/42/EEC, Medical Device Directive 2007/47/EC, FDA Quality System Regulations 21 CFR Part 820, FDA GLP Regulation 21 CFR 58, ISO 13485, ISO 14971, Japanese Ministerial Ordinance # 169.
- Support the development and evolution of Design Control, Risk Management and Product Development.
- Use your understanding of regulatory requirements for Medical Device developments, participating in specification development and advising on overall design.
- Assist R&D team for design reviews.
- Support non-clinical studies.
- Establish and maintain the design history file and associated documents.
- Work cross functionally across the quality function.
- Participate in company Audits and CAPA programs
- Degree in Engineering or Science with two years or more experience in medical device or pharmaceutical environments.
- Must have ISO13485, 21 CFR 820, MDD/MDR, Risk Management and QMS experience.
- Ideally would have Nitinol experience.
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: email@example.com
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