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.
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.
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.
Please submit your application in English. As long as the job ad is online, you can apply quickly and easily.
At Fresenius, we are convinced that combining different perspectives, opinions, experiences, cultures and values enables us to harness the potential that will make us even more successful. All job applicants are welcome.
All terms used in this job advertisement to denote persons refer to all genders equally.
When it’s not just a job, but your calling. When you have an impact on people’s lives every day. When you can’t imagine doing something else. Then you know it’s Fresenius.