Medical Device Sterilisation Expert

TN Germany; Deutschland; Remote; EUR 65.000 - 85.000; Vollzeit

Zusammenfassung

A leading company in medical device compliance is seeking a Medical Device Sterilisation Expert. This full-time role involves applying microbiological expertise to ensure compliance with sterilisation standards. Candidates should have significant experience and a relevant degree, with the opportunity for travel. A competitive salary and benefits are offered.

Qualifikationen

• Minimum of four years’ experience as a microbiologist or sterilisation engineer.
• Thorough knowledge of ISO 13485 and familiarity with MDD/MDR.

Aufgaben

• Planning, reporting, and performing audits of clients’ management systems.
• Making recommendations on issuing certificates based on device safety.

Kenntnisse

Microbiology

Quality Management

Ausbildung

Bachelor’s degree in Microbiology

Bachelor’s degree in Biology

Jobbeschreibung

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Medical Device Sterilisation Expert, Germany

Client: BSI

Location: Germany

Job Category: -

EU work permit required: Yes

Job Reference: 607899974c2e

Job Views: 3

Posted: 16.05.2025

Expiry Date: 30.06.2025

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 compliance within sterilisation, packaging, and microbiological testing outlined under ISO 13485. In this role, you will 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 a 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:

• Planning, reporting, and performing audits of clients’ management systems to ensure compliance with regulatory and voluntary requirements.
• Making recommendations on issuing certificates based on objective evidence of device safety and effectiveness.

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 a related scientific field (REQUIRED)
• Thorough knowledge of ISO 13485 and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR)
• Ability to travel 40-60% via car and plane.
• Experience in quality management, including 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 the discussion stage.

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Our Excellence Behaviours: Client-centric, Agile, Collaborative. These behaviours represent how we do things at BSI and help 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 prefer virtual, please speak to a member of our recruitment team.