Design Quality Engineer DQE - Medical Devices - Belgium - Contract
Design Quality Engineer DQE - Medical Devices - Belgium - Contract
Posted on :
04-03-2025
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1 Vacancy
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Job Description
We are seeking a Design Quality Engineer (DQE) to support R&D teams in transitioning from nonmedical to medical device development. This role is critical in ensuring compliance with medical device regulations ISOK 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 crossfunctional 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 auditready.
- Develop training programs to enhance R&Ds regulatory knowledge.
Required Qualifications
- Proven experience in developing technical files for medical devices.
- Strong knowledge of ISOK IEC 62304 and risk management.
- Excellent communication and facilitation skills for crossfunctional collaboration.
- Ability to coach and mentor teams to improve compliance and documentation quality.
- Strong problemsolving 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 cuttingedge medical devices.
- Work in a dynamic crossfunctional environment with technical experts.
- Opportunity to drive quality and compliance in medical device innovation.
Apply now to contribute to the future of medical technology!
Employment Type
Full Time
Key Skills
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