Functional Goal:
This position has primary responsibility for providing Quality Engineering oversight of Medical Devices components for Combination Products Biopharmaceuticals / Medicinal products.
Provide hands-on experience in managing quality aspects for GMP, MDR and GDP compliance of devices or device components.
Focus is on commercial and to be commercialized products.
Main Tasks:
* Lead the evaluation and qualification of suppliers / vendors in relation with device components, including quality agreement and audit program.
* Lead the evaluation of compliance of device files for products, ensuring compliance with ISO 13485, FDA (21 CFR Part 820) and EU MDR (2017/745) requirements.
* Assess design changes related to internal or external notifications and/or commitments.
* If needed, support the review and approval of technical specifications, test protocols and reports.
* Collaborate with product development, quality assurance, and regulatory teams to ensure adherence to design controls, including peripheral processes e.g. risk management process, and regulatory standards.
* Support the transfer of combination products for the device components, coordinating between internal teams, suppliers, and external stakeholders to ensure seamless integration and regulatory compliance.
* Support the preparation of technical documentation in case of (re) submission to health authorities.
Other Tasks:
* Contribute to other QM programs and GMP/MDR/GDP compliance activities as appropriate.
Qualification profile:
* Bachelor’s degree in engineering (Biomedical, Mechanical, Electrical, or related field).
* Minimum 5 years of experience in quality engineering / medical device engineering, with a strong focus on design controls.
* In-depth knowledge, strong understanding and interpretation of ISO 13485, FDA 21 CFR Part 820 and EU MDR 2017/745.
* Experience in the design and development of combination products.
* Experience with Design History Files (DHFs), including evaluation and ensuring regulatory compliance.
* Experience in Risk Management activities according to ISO 14971.
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