Quality Engineering Lead
6 days ago
About the Role
Capgemini Engineering is a world leader in engineering and R&D services, combining its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds.
This position will involve leading and supporting design control activities, ensuring compliance with FDA and international regulations.
Responsibilities:
- Lead design review meetings and participate in Design Failure Modes and Effects Analysis (DFMEA).
- Oversee verification and validation (V&V) planning and ensure compliance with FDA and international regulations.
- Support the development and review of process and equipment validation/qualification (IQ/OQ/PQ) and MSA of internal processes.
- Collaborate with suppliers, management, Engineers, and Manufacturing associates to resolve quality problems.
- Develop and execute supplier qualification processes, including supplier contracts and PPAPs.
Requirements:
- Bachelor's degree in Engineering, Quality, or a related field.
- 8+ years of experience in medical device quality engineering or a related field.
- Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and risk management (ISO 14971).
- Experience with Design Control, Process Validation, CAPA, and Supplier Quality.
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