Arion Recruitment Ltd

Design Quality Engineer (DQE) - Medical Devices - Belgium - Contract

Arion Recruitment Ltd  •  Kortrijk, BE (Onsite)  •  3 months ago
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Job Description


We are seeking a Design Quality Engineer (DQE) to support R&D teams in transitioning from non-medical to medical device development. This role is critical in ensuring compliance with medical device regulations ( ISO 13485, 510K, IEC 62304, risk management, usability, clinical evaluation) for key projects. Reporting to the PMO Lead, you will play a key role in technical file development, regulatory alignment, and cross-functional facilitation.

Key Responsibilities

  • Develop and maintain technical files for medical device projects.
  • Collaborate with project managers, software architects, security teams, and usability engineers.
  • Act as a liaison between R&D and QARA teams, ensuring regulatory clarity.
  • Coach and mentor teams on best practices in IEC 62304 and related standards.
  • Identify gaps in compliance processes and drive improvements.
  • Support audits by ensuring documentation is complete and audit-ready.
  • Develop training programs to enhance R&D’s regulatory knowledge.

Required Qualifications

  • Proven experience in developing technical files for medical devices
  • Strong knowledge of ISO 13485, 510K, IEC 62304, and risk management
  • Excellent communication and facilitation skills for cross-functional collaboration.
  • Ability to coach and mentor teams to improve compliance and documentation quality.
  • Strong problem-solving and analytical skills to identify and address process gaps.
  • Attention to detail to ensure accuracy in technical documentation.

Why Join Us?

  • Be part of an impactful R&D team working on cutting-edge medical devices
  • Work in a dynamic cross-functional environment with technical experts.
  • Opportunity to drive quality and compliance in medical device innovation.

📩 Apply now to contribute to the future of medical technology!

Arion Recruitment Ltd

About Arion Recruitment Ltd

Arion Recruitment are specialist providers of Contract and Permanent IT and Engineering resources within Europe. In the rapidly changing world of recruitment, Arion Recruitment has established itself as an organization that is quick to respond to the needs of both its worldwide client base and the high quality contractors which it supplies. We pride ourselves in offering more consultative approach, based on technical understanding, ethical business methods and with a view to building long term relationships with both clients and consultants. After 12 successful years of adopting this business model, we believe we have been proved right as our extensive blue chip client base illustrates as well as the number of consultants who return to Arion time and time again for new assignments.

With an ongoing commitment to speed of delivery, quality of performance and building relationships, we offer our Clients access to highly skilled and dedicated professionals while offering candidates potential positions in many of the leading companies in their field of expertise.

Industry
HR & Recruiting
Company Size
1-10 employees
Headquarters
Unknown
Year Founded
2002
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