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SENIOR PRODUCT QUALITY ENGINEER

The Senior Product Quality Engineer applies expertise to enhance product quality in design and manufacturing, ensuring compliance with FDA, EU MDR, and ISO 13485 standards. This role combines product engineering and quality management for devices in US and European markets.

LOCATION

Montpellier, France

EMPLOYMENT TYPE

Permanent

What You’ll Do

Under the supervision of the Quality Assurance & Regulatory Affairs Director, the key missions of the Senior Product Quality Engineer are:

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Product Development and Design Transfer Support:

  • Actively participate in product development processes, providing quality insights and technical expertise.

  • Conduct in-depth technical reviews of product designs, identifying potential quality and performance risks and improvement actions. Support root cause analysis of technical challenges and contribute to innovative problem-solving solutions.

  • Review design documentation for compliance with applicable requirements.

  • Collaborate closely with R&D engineers to develop robust design verification and validation strategies, support for design of verification and validation protocols.

  • Participate in design review meetings, providing critical quality perspective on technical feasibility and performance.

  • Define transfer of design specifications and critical-to-quality parameters to ensure seamless transition of product design to production, support the development, execution, and approval of manufacturing processes validation strategies, with the goal of highly capable processes.

  • Make sure comprehensive design transfer documentation for regulatory compliance is prepared and maintained.

  • Contribute to risk assessment for surgical robotic systems and components as well as for corresponding manufacturing processes and to development of mitigation strategies.

  • Train and guide team members on quality procedures and best practices.

  • Implement process control plans and quality control specifications for surgical robotic system components and subsystems through state-of-the-art inspection methods and technologies, assist in defining technical acceptance criteria, develop quality control work instructions.

  • Implement and ensure proper handling and calibration of measuring equipment. 

  • Ensure implementation of adequate supplier qualification and control strategies, including in handling of supplier CAPA and NC processes Provide Quality input to influence the proper selection of suppliers.

Quality Management: 

  • Elaborate, maintain and improve the Quality Management System (QMS) in compliance with FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR 2017/745.​

  • Collaborate closely with R&D and Industrialization teams to further develop quality processes throughout product development and manufacturing.

  • Manage document control system and ensure proper maintenance of quality records.

  • Participate in development and implementation of processes for CAPA, non-conformities, complaints handling and change control using company’s electronic document management system; involved in product investigations connected to those processes.

  • Participate to internal and external quality audits.

Who You are

  • Masters of Science, Engineering or related subject with 5 years of experience in a quality and
    technical discipline (mechatronics engineering preferred).

  • Experience in a highly regulated environment / industry (surgical robotics ideally, otherwise medical
    devices or other advanced technology), in development and/or design transfer activities in design projects/manufacturing/NPI involving active products. 

  • Good understanding of engineering and quality concepts/theories. Knowledge of PFMEA, GD&T,
    validation programs and statistical techniques applied to design and manufacturing.

  • Experience putting in place a quality system or significant participation in it. Knowledge of quality system reference standards, ISO 13485 is a plus. Familiar with Good Documentation Practices and Good Manufacturing Practices.

  • Experience with electronic QMS software.

  • Used to application of product standards, ideally IEC 60601 series for medical electrical equipment
    and IEC 62304 for medical device software.

  • Previous experience in Risk Management.

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