Quality Assurance Specialist

QA Specialist – Maternity Cover An exciting position for a QA Specialist (3+ years experience) to join a start-up Medical Device company (regenerative medicine) for a fixed term contract. This is a 9-12 month maternity cover position and we are beginning interviews next week. The role is Hybrid, 2-3 days remote/2-3 days on site in Nottingham per week. The Role:

• Supporting the implementation, monitoring and maintenance the QMS in line with requirements of ISO 13485:2016 and 21 CFR Part 820
• Performing internal audits, implementing CAPAs
• Supporting the QARA Director with day to day oversight
• Supporting GMP standards for clinical trial manufacturing

• Experience within a medical device space (ISO 13485 and 21 CFR Part820)
• Previous GMP experience, particularly useful if prior experience with manufacturing for clinical trials
• QMS and internal audit experience
• Ability to work onsite at least 2 days per week (based just outside of Nottingham)