(Senior) Manager Qualitätsmanagement Medizinprodukte & Kombinationsprodukte (m/w/d)

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.

Your Assignments:

• 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

• Contribute to other QM programs and GMP/MDR/GDP compliance activities as appropriate

Your 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 is preferred

• In-depth knowledge, strong understanding and interpretation of ISO 13485, FDA 21 CFR Part 820 and EU MDR 2017/745

• Experience with Design History Files (DHFs), including evaluation and ensuring regulatory compliance

• Experience in the design and development of combination products is a plus

• Experience in Risk Management activities according to ISO 14971 is preferred

• Excellent communication skills in English, both written and oral, with the ability to interact with cross-functional teams and external partners, additional language skills in French or German are a plus

• Demonstrated ability to work effectively in a team-oriented environment

• Strong analytical skills with the ability to assess product compliance and implement corrective actions

• Ability to work independently and prioritize tasks in a fast-paced environment

• Decision Making & Problem Solving

The position can be filled in Germany or in Switzerland.