This is an exciting opportunity for someone with experience in the medical device industry who is looking to develop their expertise in a fast‑paced, compliance‑driven environment.

Key Responsibilities

• Maintain and control QMS documentation in line with ISO 13485:2016.
• Conduct internal audits and support CAPA/NCR investigations and closure.
• Assist in supplier qualification, audits, and quality agreements.
• Prepare and maintain Technical Files and regulatory documentation.
• Support UKCA and CE marking activities.
• Liaise with MHRA, Notified Bodies and other global authorities.
• Manage Post‑Market Surveillance, including complaint handling and vigilance reporting.
• Monitor changes to relevant medical device regulations and standards.

About You

Essential:

• Bachelor's degree in a scientific, engineering, or life science discipline.
• 2-3 years' experience in Quality Assurance within the medical device / pharma sector.
• Knowledge of ISO 13485, UK MDR, and EU MDR (2017/745).
• Internal auditing experience.
• Excellent communication, documentation control, and technical writing skills.

Desirable:

• Experience with MDR transition audits and interacting with Notified Bodies.
• Understanding of risk management (ISO 14971) and biocompatibility (ISO 10993).
• Familiarity with eQMS platforms.
• Professional memberships (TOPRA, RAPS, CQI, ASQ).