(Senior) Manager Quality Management Medical Devices & Combination Products (m/f/d)

Fresenius SE & Co. KGaA; Bad Homburg vor der Höhe; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading company in the biopharmaceutical sector is seeking a Quality Engineer responsible for overseeing the quality aspects of medical devices. This role involves managing compliance with regulatory standards, supporting supplier evaluations, and ensuring device design controls. Ideal candidates will have a strong engineering background, extensive experience in medical device quality engineering, and excellent communication skills.

Qualifikationen

• Minimum 5 years of experience in quality engineering or medical device engineering.
• In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR 2017/745.
• Experience with Design History Files and Risk Management activities.

Aufgaben

• Lead supplier evaluations and compliance checks of device components.
• Ensure adherence to regulatory standards for product compliance.
• Support technical documentation for health authorities submissions.

Kenntnisse

Quality Engineering

GMP Compliance

Design Controls

Regulatory Compliance

Risk Management

Communication Skills

Analytical Skills

Ausbildung

Bachelor’s degree in Engineering

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.