R&D Quality Engineer - Molecular F/M/D

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For more than 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 46 countries and serve 160 countries with the support of a large distribution network.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.

Our Global Quality team is seeking an R&D Quality Engineer – Molecular (F/M/D), reporting to the R&D Quality Manager for Molecular. You will play a key role in quality assurance and compliance throughout product development and the lifecycle of the Molecular product range.

What will be your main responsibilities at our company?

• Design control Expertise & Quality operations
  • Support R&D product development projects and be accountable for applying Design Control requirements
  • Ensure and maintain product quality and compliance during development and throughout the product lifecycle.
  • Act as the R&D Quality representative within Molecular project teams, ensuring compliance with applicable regulations and standards.
  • Support internal, customer, and corporate audit processes to ensure regulatory alignment.

• Molecular Development and Risk Management Knowledge
  • Provide Quality oversight for the end‑to‑end development of Molecular consumables and systems, including instrumentation, system integration, and software components ensuring robust application of Design Control principles.
  • Assess and support activities related to molecular product development including software, ensuring compliance to applicable standards such as IEC 62304
  • Help identify impacts on design files and support design changes by assessing impacts to design documentation, verification/validation activities, and risk management files.
  • Support product risk management activities (during development and lifecycle management) for the Molecular product range.
  • Provide R&D Quality support on product risks to other Quality teams for non-conformities, deviations, investigations, change control, CAPA, and Anomaly Review Boards.

• Cross-functional Collaboration & Continuous Improvement
  • Contribute to the harmonization and improvement of Quality practices within teams.
  • Strengthen interactions with stakeholders by sharing Quality best practices.
  • Contribute to the post-market surveillance reports.

Who are you ?

• Minimum 5 years of experience as a Quality Engineer in the healthcare industry (IVD, Medical Devices, Biotech, or Pharma).
• Master’s degree in a scientific field or equivalent industry experience.
• Strong experience in R&D, Product Development, Design Controls, Technical Support, QE/QA/QC, or Regulatory Affairs.
• Experience in Systems and Software Quality in IVD or Medical Devices is required.
• Knowledge in biology (particularly molecular) is appreciated but not mandatory.
• Proficiency in applicable medical device standards and regulations: ISO 13485, 21 CFR 820, EN 62366, IEC 62304, ISO 14971, 21 CFR, MDR 2017/745, IVDR 2017/746, CLSI.
• Excellent analytical, problem-solving, and organizational skills, with the ability to challenge processes and drive continuous improvement.
• Strong communication and stakeholder management skills.
• Fluency in English and in French (written and spoken) required to work in an international environment.

Additional Information

• Position based in Grenoble, with approximately 5% travel expected across sites in the Lyon area (Marcy/La Balme).
• For this recruitment process, please prepare both an English and a French version of your resume. 

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.