Quality Assurance Specialist

Quality Assurance Specialist

Posted 3 days ago by Step on Reed

£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