Quality Engineer - Industrial Diagnostics & Lifecycle Quality

Biomerieux; Craponne; On-site; EUR 55,000 - 75,000; Full time

Job summary

bioMérieux seeks a Quality Engineer to join the Global Industrial Applications - Pre and Post Market Quality team. You will oversee quality processes across the product lifecycle for industrial diagnostics, including reagents, instruments and software, ensuring compliance with global standards.

You will lead design control, risk management and field actions, coordinating audits and continuous improvement activities with cross-functional teams worldwide.

Qualifications

• Bachelor's degree, master's preferred, with more than 4 years of industry experience.
• Experience in quality job and design control for reagents and/or instruments is preferred.
• Knowledge of ISO 9001, ISO 13485, ISO 14971, 21CFR820, GAMP, 21CFR11, GMPs, ISO 16140 and related standards.
• Experience in regulatory audits (ISO 9001, ISO 13485, FDA, etc.) and interpreting international regulations.

Responsibilities

• Monitor the product portfolio for Industrial diagnostics (Pharma Quality and Food Safety and Quality).
• Be the preferred contact and guarantor of quality processes throughout the product lifecycle.
• Coordinate Field Action Board meetings and interface with GiCS representatives and site quality managers.
• Support audit preparation and act as audit liaison for development and field actions on the portfolio.
• Contribute to continuous improvement initiatives and harmonization of practices.

Skills

Molecular biology

Microbiology

Diagnostic product development

Quality management systems

Analytical skills

Education

Bachelor's Degree

Master's degree preferred

Job description

bioMérieux seeks a Quality Engineer to join the Global Industrial Applications - Pre and Post Market Quality team. You will oversee quality processes across the product lifecycle for industrial diagnostics, including reagents, instruments and software, ensuring compliance with global standards.

You will lead design control, risk management and field actions, coordinating audits and continuous improvement activities with cross-functional teams worldwide.