Job Description
We are seeking a Quality Assurance Specialist to provide day-to-day quality support on our manufacturing lines.
This role ensures compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and our internal Quality Management System.
Key Responsibilities
1. Performing production audits, inspections, and ensuring Good Manufacturing & Documentation Practices (GMP/GDP)
2. Managing non-conforming materials and supporting root cause investigations
3. Maintaining and reporting quality metrics
4. Supporting internal/external audits and regulatory compliance
5. Assisting in documentation, process improvements, and lean initiatives
Required Skills and Qualifications
The ideal candidate will have a degree in a quality-related discipline and at least 25 years of experience in a regulated manufacturing environment (Medical Device or Pharma).
Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR is essential, as well as excellent communication and documentation skills and proficiency in Microsoft Office.