Quality Advocate: QA Project Manager (Med Devices)

Coloplast; Denmark; Hybrid; DKK 700,000 - 900,000; Full time

Job summary

Coloplast is seeking a QA Project Manager to advocate quality from ideation to market introduction. Based at our Humlebæk HQ, you’ll lead a core team across regulatory, production QA, process validation, biosafety, sterilization, and more, ensuring design control and regulatory compliance.

You should have a bachelor’s degree in Engineering or Pharmacy, 5+ years in medical devices or pharma QA/R&D, and fluent English. The role includes international travel ( Hungary ) and a hybrid work setup.

Qualifications

• Bachelor’s degree in Engineering, Pharmacy or similar.
• Minimum 5 years of experience in the medical device or pharmaceutical industry within Quality Assurance and/or R&D.
• Experience with project management or desire to grow into it.
• Familiar with ISO13485 and US FDA demands.
• Speak and write English effortlessly.

Responsibilities

• Manage and guide quality specialists and ensure on-time project deliverables.
• Assess, manage and mitigate product and project risks.
• Ensure successful design transfer by collaborating with R&D, Pilot site and Production sites.
• Report to management on milestones, risks and issues.
• Review and approve relevant design control documentation.
• Optimize and update quality processes with stakeholders.

Skills

Communication

English

Education

Bachelor's degree in Engineering or Pharmacy

Job description

Coloplast is seeking a QA Project Manager to advocate quality from ideation to market introduction. Based at our Humlebæk HQ, you’ll lead a core team across regulatory, production QA, process validation, biosafety, sterilization, and more, ensuring design control and regulatory compliance.

You should have a bachelor’s degree in Engineering or Pharmacy, 5+ years in medical devices or pharma QA/R&D, and fluent English. The role includes international travel ( Hungary ) and a hybrid work setup.