Quality Engineer

Quality Engineer.

Quality Engineer

Eindhoven

|

€60000 - €70000 per year

|

Permanent

|

Quality Assurance

To Apply for this Job Click Here

Join a Medical Device company making a real difference! - Apply Now!

Title: Quality Engineer

Reporting To: Head of QA

Industry: Life Sciences - Medical Devices

Salary: upto €7,000/month

We're seeking a dynamic and experienced Quality Engineer to join our client's team and play a pivotal role in ensuring the safety, reliability, and exceptional quality of their active implantable medical device system. Collaborating closely with their system architect, R&D team, and external technology partners, you'll spearhead medical device compliance activities across the entire product lifecycle, facilitating their entry into the EU and US markets. As a key member of their multidisciplinary team, you'll take ownership of quality assurance, employing a pragmatic approach and demonstrating a relentless commitment to excellence.

KEY RESPONSIBILITIES

  • Enforce adherence to our client's design and development procedures within R&D projects.
  • Maintain compliance with relevant standards and regulations, including EU MDR, FDA, ISO 13485, IEC 62304, and IEC 60601.
  • Lead quality checks to ensure products meet stringent standards, collaborating closely with the team.
  • Review documentation to uphold good documentation practices and ensure QMS compliance.
  • Drive root cause analyses of quality issues and develop effective corrective actions.
  • Collaborate with procurement to establish and maintain quality requirements for external suppliers.
  • Provide support for design transfer activities to manufacturing.

YOUR PROFILE

  • Proven experience in quality engineering within a production or product development environment, preferably in medical devices or pharmaceuticals.
  • Thorough understanding of relevant regulations and standards.
  • Excellent verbal and written communication skills in English.
  • Strong analytical mindset with a practical approach to problem-solving.
  • Proactive in defining work priorities and identifying improvement opportunities aligned with quality and business objectives.
  • Bachelor's or master's degree in (Bio)Medical Engineering, Electrical Engineering, or equivalent.

Join our client's groundbreaking journey to revolutionize healthcare through cutting-edge bioelectronics. If you're passionate about quality and driven to make a difference, we want to hear from you.

Please apply or email james.allen@darwinrecruitment for more information.

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.

James Allen

To Apply for this Job Click Here

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