Sterility Assurance Associate - Remote

Group Sterility Assurance Associate (12-Month FTC - Maternity Cover) - Remote - Up to £45,000 pa -

Remote Working | Full-Time | 12-Month Fixed-Term Contract

An exciting opportunity has arisen to join a global, innovation-led medical device manufacturer as a Group Sterility Assurance Associate on a 12-month fixed-term contract (maternity cover).

The business develops and supplies innovative medical technologies used internationally and operates across the UK, Europe, the USA, and additional global markets. With multiple manufacturing sites and R&D hubs across Europe and internationally, the business is continuing to strengthen its group-level quality and compliance capabilities.

This is a remote-based, group-level position acting as the Sterility Assurance Subject Matter Expert (SME) across multiple sites, ensuring compliance with global sterilisation standards, cGMP, MDSAP and MDR requirements.

• Degree (or equivalent) in a scientific discipline, or a minimum of 2+ years' experience within medical devices or pharmaceuticals
• Experience with at least one major sterilisation method (Gamma or EO) and application of relevant ISO standards, or microbiology experience within medical devices
• Knowledge of EU Medical Device Regulation (MDR)
• Working knowledge of cGMP / cGLP requirements
• Understanding of ISO 13485 (Lead Auditor training desirable but not essential)
• Ability to independently manage moderate to complex technical issues
• Experience managing multiple projects simultaneously

This role would suit a Sterility Assurance, Microbiology, or Quality professional with experience in Gamma or EO sterilisation within a medical device or pharmaceutical environment.

To apply for this role, please call and/or send your CV to David Hopkin