Medical Device Auditor - Organics (m/f/x)

TN Germany; Deutschland; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading company is seeking a Medical Device Auditor to assess ISO 13485 quality management systems across Europe, the Middle East, and Africa. The role involves extensive travel and requires fluency in German and English, along with relevant experience in medical device manufacturing. Candidates will receive training in ISO standards and will be responsible for conducting audits and reporting findings.

Qualifikationen

• 4+ years in design/test/manufacture of IVD/organic medical devices.
• 2+ years in a Quality Management System environment.

Aufgaben

• Conduct audits on site or remotely.
• Write reports and manage audit schedules.

Kenntnisse

German

English

Resilience

Ausbildung

Degree in relevant discipline

Jobbeschreibung

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Medical Device Auditor - Organics (m/f/x), field based, germany

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Client:

BSI

Location:

Job Category:

-

EU work permit required:

Yes

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Job Reference:

b0452f1022e9

Job Views:

1

Posted:

16.05.2025

Expiry Date:

30.06.2025

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Job Description:

Medical Device Auditor - Organics (m/f/x)

Germany – travel required

As a Medical Device Auditor, you’ll travel to medical device manufacturers across Europe, Middle East and Africa and occasionally USA. You’ll help these manufacturers to improve their performance by assessing their ISO 13485 quality management system, so they can ensure patient safety and comply with regulatory procedures.

In the first six months of being a Medical Device Auditor you’ll:

Be given training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme) and MDR (Medical Device Regulation)

Initially observe how audits are conducted but then grow to conduct them on an individual basis on site at medical device manufacturers across EMEA and remotely from your home office

In a typical week after being fully trained you’ll:

Conduct an audit on site or remotely

Write up your reports and liaise with the planning team to manage your audit schedule.

You’ll also continue your development of MDR and be an advocate for the ISO 13485 EMEA Delivery Team.

To thrive in this career, you must:

Have 4 years or more being directly accountable for the design or test or manufacture of IVD or organic medical devices

Be degree educated with discipline relevant to IVD/organic devices e.g. chemistry, physical chemistry, molecular genetics, textiles, material science, biology, biotechnology or similar

Demonstrate your experience with IVD reagent/assay development or other medical device coatings/textiles/materials

Have at least 2 years’ experience working in an environment with a Quality Management System established

Be able to speak and write fluently in German and English languages

Be resilient and able to meet audit delivery by travelling frequently across the EMEA region as required

We’re enthusiastic to receive applications from those based in Germany excited by this career opportunity.