Quality Assurance Auditor

5 days ago

Region Zealand, Denmark Black Swans Exist Full time 60,000 - 120,000 per year

Quality Assurance Auditor – Medical Device

Are you an experienced Quality Assurance
Auditor who thrives on structure, cross-functional collaboration and ensuring that quality systems stand strong? Would you like to play a key role in driving internal and external audit readiness within a global medical device organisation?

Our client, a class 3 medical device family-owned company, is looking for a Quality Assurance Auditor to join their Quality Assurance organisation — a team of 40+ QA professionals supporting the full value chain at their Danish manufacturing sites.

About the role

You will join a small but highly specialised Audit team (you + one colleague), responsible for planning, executing, and improving internal audit programmes. You will also support the preparation and hosting of third-party audits (on-site, remote and desktop), working closely with the Quality Systems team to ensure the QMS meets all applicable standards and regulatory requirements.

In this role, you will:

  • Plan, coordinate and conduct internal audits across the organisation
  • Prepare and support external audits from notified bodies and authorities
  • Strengthen and continuously improve audit processes and documentation
  • Collaborate widely across operations, engineering, QA, and global functions
  • Contribute to maintaining an effective and compliant QMS (ISO 13485, MDR 2017/745)
  • Help ensure that products reach patients worldwide safely, effectively and on time

Who you are

You will thrive in this role if you enjoy working with details, documentation and processes — while also engaging with colleagues across the organisation. You appreciate structure, clarity and continuous improvement, and you are motivated by being a trusted QA-partner for the business.

We imagine you bring:

  • A scientific, health-technical, engineering or similar background
  • Experience from a similar QA Auditor role in medical devices or another regulated industry
  • Strong knowledge of ISO 13485 and MDR (2017/745)
  • Experience with internal audits (and ideally external/third-party audits)
  • Certification as an auditor is an advantage
  • Strong communication skills in Danish and English
  • A collaborative and open approach — you enjoy knowledge sharing and being part of a team

The offer

You will join a company known for its strong culture, supportive environment and pride in delivering high-quality medical devices to patients around the world.

  • A structured and comprehensive onboarding programme
  • A flexible work environment with a focus on trust and responsibility
  • Competitive salary package including bonus and pension
  • Health insurance and various employee associations (Sports, Arts, etc.)
  • Excellent canteen and access to on-site fitness centre
  • A global company with 10,000+ employees — and 700 colleagues in Denmark

About the company

The company is a family-owned global company developing minimally invasive medical technologies that improve patient outcomes and support life-saving procedures. The Danish sites contribute directly to this mission with high-quality products and strong craftsmanship — driven by our unique spirit: openness, dedication, pride and collaboration.

Interested? Send us your application and CV as soon as possible. We will review applications on an ongoing basis.

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