Senior Quality Assurance Manager

2 weeks ago


Stockholm, Stockholm, Sweden EPM Scientific Full time

Join Our Team as a Senior QA Manager

Location: Nordics

Company: Our client is a Top Medical Device Organisation

Job Type: Hybrid

Date: URGENT To be shortlisted ASAP

About Us:

Step into the future of healthcare with a leading medical devices company that's redefining innovation and quality. We're committed to improving patient outcomes and delivering cutting-edge solutions that make a real difference.

Role Overview:

Our client is on the hunt for a dynamic and experienced Senior QA Manager to spearhead their Quality Assurance initiatives. This is your chance to drive excellence, lead a talented team, and shape the future of medical technology

Key Responsibilities:

  • Lead the charge in maintaining a world-class Quality Management System (QMS) compliant with FDA and ISO 13485 standards.
  • Inspire and mentor a top-tier QA team, fostering a culture of continuous improvement.
  • Conduct and manage high-stakes internal and external audits, including MDSAP, DEKRA, and FDA.
  • Drive impactful CAPA (Corrective and Preventive Action) plans and root cause analysis.
  • Oversee complaint handling and adverse event reporting, ensuring processes remain validated.

What You Bring:

  • 5+ years of senior QA experience in the medical devices industry.
  • Deep knowledge of FDA regulations, ISO 13485, and global standards.
  • Proven leadership skills with a knack for managing high-performing QA teams.
  • Strong experience in product development and production quality management.
  • Bachelor's degree in a relevant engineering field; Quality Assurance certifications (Six Sigma, Lean, ASQ) are a plus.

Why You'll Love It Here:

  • Join a pioneering team driving medical innovation.
  • Collaborate in a vibrant, growth-focused environment.
  • Competitive salary and comprehensive benefits package.

Ready to Make an Impact?

Send your CV and a brief cover letter to or apply directly through LinkedIn. For more info, contact lets organise a chat to discuss further

Let's revolutionise Medical Devices together


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