Responsibilities
:
1. Ensure compliance to global Design Control and Risk Management procedures, which adhere to ISO, ISO, MDSAP and MDD/ MDR.
2. Developing and reviewing documentation for clinical trials, product/process development, and validation.
3. Supporting the development of inspection methodologies and acceptance criteria.
4. Assisting in maintaining Quality System Regulation requirements and participating in audits.
5. Fostering a culture of quality awareness and teamwork.
6. Collaborating with Regulatory Affairs and R&D to ensure compliance with applicable standards.
7. Participating in Regulatory Agency Inspections and supporting Manufacturing in Validation and Control Planning.
Requirements:
8. Extensive experience in the medical device field, preferably in Vitro Diagnostics or Pharma.
9. Bachelor's degree in engineering or a related science discipline.
10. Technical proficiency in quality systems, including ISO standards and FDA regulations. This includes practical application of ISO, ISO, and FDA Quality System Regulation CFR 21 Part. MDSAP & MDD/ MDR is ideal.
11. Experience with Good Manufacturing Practice (GMP) and ideally with Good Laboratory Practice (GLP) or Good Clinical Practice (GCP).
12. Knowledge of Qualitative and Quantitative data analysis and statistical tools.
13. Six Sigma Green Belt or Certified Quality Engineer (CQE) qualification preferred.
14. Project Management certification is a plus.
Benefits:
In addition to competitive compensation, they offer a comprehensive benefits package, including 25 days of holiday, a pension scheme, Private Medical coverage, life assurance, access to their Wellness Platform, discounted contact lenses, and more.
Apply via Linked In, or alternatively, you can contact me on +44 23 or email me at