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Director, Quality Competence Centre

Coloplast A/S · Humlebæk

New
🇬🇧 English
ISO 13485 EU MDR FDA regulations

Job description

About the role

Lead Coloplast’s Global Quality Competence Centre from its headquarters in Humlebæk, overseeing an international team of about 45 employees in Denmark, Hungary and Poland. Reporting to the VP of Global Quality, you will shape the strategic direction of quality across the company and influence enterprise‑wide decisions.

Key responsibilities

  • Lead the Quality Competence Centre through three direct‑report managers, coordinating activities across Denmark, Hungary and Poland.
  • Define and drive the strategic agenda for Sterilization, Microbiology, Supplier Quality, Biosafety and Chemical Compliance.
  • Steer supplier quality management reviews in partnership with Direct Procurement.
  • Ensure resources are available for internal and external audits, monitor departmental performance and report results.
  • Engage and mobilise stakeholders in R&D, Operations, Procurement and Regulatory Affairs to align on quality objectives.
  • Support the entire product lifecycle, from innovative device development to compliance of legacy products, enabling faster time‑to‑market.
  • Travel internationally approximately 20 days per year.

Required profile

  • Extensive experience in Quality Management, preferably within the medical‑device or other highly regulated industry.
  • Minimum five years of people‑management experience, including leading other managers.
  • Proven ability to lead multi‑country teams and work in an international environment.
  • Fluent written and spoken English.

Required skills

  • Knowledge of ISO 13485 quality management systems.
  • Familiarity with EU MDR regulatory requirements.
  • Understanding of FDA regulations for medical devices.

Questions fréquentes

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Source : ats:successfactors

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Published 1 day ago

Expires 1 month from now

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Coloplast A/S

Humlebæk