Job Description
This role is responsible for providing quality engineering oversight of medical devices components for combination products biopharmaceuticals / medicinal products.
The ideal candidate will have hands-on experience in managing quality aspects for GMP, MDR and GDP compliance of devices or device components.
The focus is on commercial and to be commercialized products.
Main Responsibilities
* Lead the evaluation and qualification of suppliers / vendors in relation with device components, including quality agreement and audit program.
* Evaluate compliance of device files for products, ensuring adherence to 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.
* Support review and approval of technical specifications, test protocols and reports as needed.
* 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 transfer of combination products for the device components, coordinating between internal teams, suppliers, and external stakeholders to ensure seamless integration and regulatory compliance.
* Prepare technical documentation in case of (re) submission to health authorities.
Additional Responsibilities:
* Contribute to other quality management programs and GMP/MDR/GDP compliance activities as appropriate.
Qualification Requirements
* 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 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.