Medical Device QA and RA Manager

5 days ago


Gothenburg, Västra Götaland, Sweden Randstad Full time

Randstad seeks a talented Medical Device QA and RA Manager to oversee the quality assurance process and ensure compliance with industry regulations.

This role will involve working closely with internal stakeholders to develop and implement quality systems and regulatory strategies.

Main Responsibilities:
  • Oversee the entire quality assurance process from design to delivery.
  • Ensure compliance with relevant regulations and industry standards.
  • Develop and maintain relationships with key stakeholders including suppliers and partners.
Requirements:
  • Bachelor's degree in a relevant field such as life science or engineering.
  • At least 5 years of experience in quality assurance and regulatory affairs in the medical device industry.
  • Proven track record of delivering high-quality results and meeting deadlines.
  • Familiarity with relevant regulations including MDR and 21CFR Part 820.


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