£40,000 Per year
Fixed-Term
Hybrid
Beeston, Nottingham, Nottinghamshire
Summary: The Quality Assurance Specialist role at a regenerative medicine company focuses on supporting the Quality Assurance & Regulatory Affairs function. The position involves maintaining and improving the Quality Management System in compliance with ISO 13485:2016 and 21 CFR Part 820. The specialist will lead document control and ensure compliance through various quality assurance activities. This is a fixed-term contract position with flexible working options available.
Key Responsibilities:
- Maintain and update QMS databases, including Document Register, Non-Conformances, CAPAs, Change Controls, Training, and Standards.
- Chair Change Control Committee meetings and oversee the progress of change controls.
- Oversee supplier review, approval, and monitoring to ensure material and service quality.
- Ensure effective handling of non-conformances, CAPAs, feedback, and complaints.
- Support third-party audits and regulatory inspections.
- Implement new Policies.
- Conduct internal audits in line with the internal audit programme.
Key Skills:
- Degree in a life sciences or related discipline, or equivalent experience.
- Experience in a medical sector working within ISO 13485:2016 is essential.
- Experience with 21 CFR Part 820 is an advantage.
- Prior experience conducting internal audits within a QMS environment (preferred).
- A proactive, can-do attitude with the ability to meet ambitious goals.
- High levels of integrity, able to work independently with minimal supervision.
- Strong communication skills, comfortable working within a small, flexible, and fast-paced team.
Salary (Rate): £40,000
City: Beeston
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: fixed-term
Seniority Level: Mid-Level
Industry: Other