Medical Device Quality Assurance Specialist

4 days ago


Århus, Århus Kommune, Denmark The HubDanske Bank Full time
About the Role

We are seeking a highly skilled Medical Device QA/RA specialist to join our Clinical and Regulatory team.

Job Description

This role is responsible for defining and delivering on our strategy to maintain superior product quality, placing products into new markets, and maintaining existing ones. As a QA/RA specialist, you will become an expert in all corners of our Quality Management System, engaged in all stages of product development and ensuring internal quality processes are well-oiled.

  • Co-drive product release projects with the development team.
  • Support other departments in design control.
  • Lead risk analysis for new products with support from clinical and development teams.
  • Review and revise QMS procedures for efficiency and effectiveness.
  • Assist management in prioritizing regulatory approval activities based on strategy and market potential.
  • Create and coordinate product submissions for developed devices.
  • Train the company in QMS procedures.
  • Participate in audits, both internal and external.

Your Journey

  • You'll get familiar with your new colleagues, products, and previous QA/RA projects within two weeks.
  • After one month, you'll work on design control projects, participate in risk management activities, and have had 1:1 meetings with your manager.
  • In three months, you'll drive CAPAs, communicate with authorities worldwide, and plan further professional development.
  • After six months, you'll lead technical documentation, review and approve procedures and quality records, and play a pivotal role in reaching new markets.


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