Medical Device Sterilisation Expert

Great that you're thinking about a career with BSI!

About the role :

Are you a Microbiologist, Sterilisation Engineer, or Quality Manager looking for an interesting career change? Then this could be the opportunity for you!

Here at BSI we hire qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilisation, packaging and microbiological testing outlined under ISO 13485. In this role you will have the opportunity to apply your sterile medical device experience to impact patient safety and help determine which new products go to market.

This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits.

This is an EMEA home-based position with 40-60% travel to client sites (once COVID-19 restrictions lift) so candidates must be located near a major airport.

Technical Specialist Responsibilities :

Responsible for planning, reporting and performing of audits of clients’ management systems ensuring compliance with regulatory and voluntary requirements.

Conduct comprehensive in-depth medical device reviews (including sterilisation validation).

Make recommendation whether to issue a certificate, based on objective evidence that the device is safe and effective.

Education / Qualifications :

A minimum of four (4) years’ experience working as a microbiologist and / or sterilisation engineer for a sterile medical device manufacturer (REQUIRED)

Bachelor’s degree (or higher) in Microbiology, Biology or related scientific degree (REQUIRED)

Thorough knowledge of ISO 13485 quality standard and familiarity with Medical Devices Directive (MDD) / EU Medical Device Regulation (MDR)

Ability to travel 40% to 60% via car and plane.

ISO 13485 Lead Auditor experience desirable.

Quality management experience including significant participation in third party quality audits

What we offer :

We offer a competitive salary and benefits package dependent on the country, more details can be provided at discussion stage.

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Our Excellence Behaviours : Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.