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

Fresenius SE & Co. KGaA; Bad Homburg vor der Höhe; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading company in the medical device sector is seeking a Quality Engineer responsible for quality oversight and compliance of combination products. The role involves leading supplier evaluations and ensuring regulatory adherence, requiring a strong background in quality engineering and relevant experience in the medical device industry. Ideal candidates have excellent communication skills and the ability to work effectively in cross-functional teams.

Qualifikationen

• Minimum 5 years of experience in quality engineering / medical device engineering.
• In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR 2017/745.
• Excellent communication skills in English; additional language skills in French or German are a plus.

Aufgaben

• Lead evaluations and compliance checks of device files and quality agreements.
• Support technical documentation for health authority submissions.
• Collaborate with teams to ensure adherence to design controls and regulatory standards.

Kenntnisse

Quality Engineering

Analytical Skills

Communication

Problem Solving

Ausbildung

Bachelor’s degree in engineering (Biomedical, Mechanical, Electrical, or related field)

Jobbeschreibung

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.