Medical Device Sterilisation Expert

BSI; Deutschland; Remote; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

A leading company in medical device safety is seeking a Medical Device Sterilisation Expert. This full-time role involves auditing and ensuring compliance for sterilisation processes. Ideal candidates are microbiologists with significant experience and a bachelor's degree. The position entails remote work with considerable travel, targeting candidates located near major airports.

Leistungen

Competitive salary

Annual bonus

Great benefits

Qualifikationen

• Minimum of 4 years’ experience in microbiology or sterilisation engineering for medical devices.
• Thorough knowledge of ISO 13485.
• Ability to travel 40% to 60%.

Aufgaben

• Plan, report, and perform audits of clients’ management systems.
• Decide on certification issuance based on evidence of device safety.
• Ensure compliance with regulatory requirements.

Kenntnisse

Microbiological Testing

Sterilisation Engineering

Quality Management

Ausbildung

Bachelor’s degree in Microbiology

Bachelor’s degree in Biology or related scientific degree

Jobbeschreibung

Social network you want to login/join with:

Medical Device Sterilisation Expert, germany

col-narrow-left

Client:

BSI

Location:

germany, Germany

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Reference:

607899974c2e

Job Views:

3

Posted:

21.06.2025

Expiry Date:

05.08.2025

col-wide

Job Description:

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.

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 asterile 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.

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.

#LI-SC2

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.