Senior Quality Systems Engineer – Start-up
- Act as an SME and leader for application and development of quality systems onsite with specific regard to ISO standards including ISO13485:2016 & ISO14971:2007 or MDR regulations on MDD93/42/EEC, MDR/2017/745, SOR/98-282. 21CFR820 & 21CFR11
- Promote awareness onsite and implement best industry practice, acting as a champion for continuous improvement in an innovative and fast paced environment.
- Implementing internally all regulatory and legal requirements, working directly with the Senior Quality Manager to align internal QMS requirements for ISO13485:2016 & 21CFR820.
- Lead and support regulatory inspections and notified body audits.
- Conduct internal audits to support the supplier quality management process.
- Compile management review data, quality metrics and help in driving continuous improvement for the quality system.
- Provide input into equipment and process validation and test method validation.
- Level 8 degree or post graduate degree in quality management or similar
- 5 years or more experience in a medical device manufacturing environment with direct working experience in a QMS role.
- Working knowledge of FDA, ISO13485 or CE Registration process.
- Experience in regulatory submissions is preferable but not absolutely required.
- Lead auditor certification an advantage
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: email@example.com
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