Auditor*in Medical IVD (w/m/d)

Job ID: 16762

TÜV Rheinland LGA Products GmbH

Permanent, Full Time

Cologne

Immediately

Das ist Dein Aufgabenfeld

TÜV Rheinland LGA Products GmbH ist ein international agierendes Unternehmen mit dem Fokus auf Marktzugang von Produkten und Dienstleistungen inklusive der Prüfung, Begutachtung und Zertifizierung von Medizinprodukten.

Werden Sie ein Teil der TÜV Rheinland Products GmbH und somit Expertin und Experte, die sich verantwortungsvollen Herausforderungen stellen.

  • Als Auditor wirst Du Qualitätsmanagementsysteme von In-vitro-Diagnostik Herstellern auf der Basis von aktuellen Qualitätsmanagementnormen (bspw. EN ISO 13485) und weiterer internationaler regulatorischer Anforderungen (bspw. IVDD, IVDR, MDSAP) vor Ort bewerten.
  • Diese Reisetätigkeit wird Dich nicht nur in unterschiedliche Regionen innerhalb von Deutschland führen, sondern auch ins europäische und außereuropäische Ausland und beinhaltet Übernachtungen in den entsprechenden Regionen.
  • Sobald Du unser extensives Training erfolgreich abgeschlossen hast, bist Du für die fachliche Betreuung von nationalen und internationalen Kunden verantwortlich und kannst Dich zu unterschiedlichen Themen in internationale Projekte einbringen.

Das brauchst Du dafür

Du bringst ein erfolgreich abgeschlossenes Studium im Naturwissenschaftlichen Bereich (Biochemie, Chemie Medizintechnik, Biomedizinischen Labordiagnostik) oder einer vergleichbaren Disziplin mit und hast ein Verständnis für Qualitätsmanagementsysteme (e.g. ISO 9001/ ISO 13485) und relevante Sicherheitsstandard.

Um Deine Karriere-Reise bei TÜV Rheinland erfolgreich zu starten, brauchst Du 4 Jahre Erfahrung im Industriebereich der Medizinprodukte und bist individuell verantwortlich für ein oder mehrere der folgenden Themen:

  • R&D (Research & Development)
  • Design/Design-Entwicklung
  • Service, Wartung und/oder Testung
  • Herstellung/Produktentwicklung

Wir bereiten Dich optimal auf deine neuen Tätigkeiten vor und bieten Weiterbildungen wie ISO 13485 Lead Auditor Kurs, MDSAP (Medical Device Single Audit Programme) und MDR/IVDR Regulation Training.

Diversity & Inclusion

Equal opportunities are particularly important to us at TÜV Rheinland. We are committed to breaking down barriers and creating an inclusive working environment characterised by respect, diversity and genuine participation. We therefore particularly welcome applications from people with severe disabilities.

Recruiter

Willi Berks

Recruiting

Responsible for recruiting for this position

We only accept applications submitted online through our application system. We cannot accept applications sent by email.

What else you should know

Job ID16762
Type of contractPermanent
Type of employmentFull Time
Work modelHome Office / fully remote
CompanyTÜV Rheinland LGA Products GmbH

Application deadline: as long as the job is listed on our career page, we are looking for suitable candidates (all genders welcome). We are looking forward to receiving your application.

You can look forward to that:

Flexitime & annual working time account

Enables fair conditions and individualised working hours

Flexible working hours

Family-friendly arrangements such as working from home and part-time work

Travelling time = working time

Every assignment at home and abroad is counted as regular working hours

38.5-hour week

Healthy work-life balance thanks to sufficient free time

Further training programmes

From coaching and mentoring programmes to the ‘Women's Network’

30 days holiday

A matter of course for us. Plus Christmas Eve and New Year's Eve

Flat hierarchies

We value trusting collaboration in interdisciplinary teams

Mobile wokplace models

Work according to your needs, regardless of location.

Products image

Products

In the Products business unit at TÜV Rheinland, we are looking for talents who want to stand with us at the forefront of safety, quality, and innovation. Our goal is to make products safe and compliant with standards in international markets – from consumer goods to highly complex medical devices. In doing so, we support companies in complying with national and international standards.

Our focus is on the challenges of digitalization, sustainability, and global trade requirements. Whether smart technologies, sustainable materials, or the safety of connected products – we actively shape the future of product safety.

Our Core Areas:

  1. Softlines: Testing, inspection, and certification services for textiles, clothing, footwear, leather goods, and other consumer products.
  2. Hardlines: Safety and quality testing for household goods, toys, furniture, sports equipment, tools, and DIY products.
  3. Electrical: Testing and certification of electrical and electronic products, from household appliances to industrial control systems.
  4. Solar & Commercial: Quality assurance and certification of photovoltaic modules, inverters, and commercial technical installations.
  5. Medical: Comprehensive testing and certification for medical devices, from diagnostic equipment to implants, including regulatory consulting.

Join a Strong Team!

At TÜV Rheinland, you can contribute and expand your expertise in an international environment. We offer a dynamic work environment that fosters innovation, embracing diversity and continuous learning. Together, we shape a future where safety and quality go hand in hand.

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Things to know about jobs and applications

Things to know about jobs and applications

Freelancers

Freelancers

Are you interested in working at TÜV Rheinland, but would prefer to work on a freelance basis?

meet TÜV Rheinland

meet TÜV Rheinland

TÜV Rheinland is regularly on the road. Visit us at one of the job and career fairs.

Your application process

1. Online application

You can only apply online via our careers page. The application process is very simple and only takes a few minutes.

Your contact person

Recruiter

Questions about your application
Our recruiters will be happy to answer any questions about the position or the application process by email:

Willi Berks

Recruiting

General questions are answered by the TÜV Rheinland hotline.

Applications are only accepted online via our application system.

Direct application

Meet us on Social Media

#todayfortomorrowTR

Follow us for more insights

Would you like to learn more about the company and gain insights into our working world? On our social media channels, you can take a direct look behind the scenes at TÜV Rheinland. Current projects, career events, and feedback from employees – we keep you up to date.

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