Quality Assurance Engineer - IT Solutions and Cybersecurity R&D W/M

bioMérieux; La Balme-les-Grottes; Sur place; EUR 45 000 - 65 000; Plein temps

Résumé du poste

A global diagnostics company is seeking a Quality Assurance Engineer for the IT Core Assets program. The role involves leading quality for IT commercial solutions, ensuring compliance with international standards, and conducting risk management. Ideal candidates will have over 3 years of experience in Quality Engineering, possess strong communication skills, and be fluent in both English and French. This position offers opportunities for growth within a dedicated team focused on quality in healthcare technology.

Qualifications

• Experienced in quality engineering within a software environment.
• Knowledge of international standards like ISO 13485, ISO 14971.
• Excellent communication and negotiation skills.

Responsabilités

• Lead Quality for IT commercial solutions.
• Champion cybersecurity quality processes.
• Design and maintain Risk Management Files.

Connaissances

Quality Engineering

Cybersecurity

Risk Management

Cross-functional team leadership

Analytical thinking

Fluent in English and French

Formation

3+ years in Quality Engineering or related role

Advanced knowledge of ISO 13485, ISO 14971

Description du poste

Overview

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 45 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.

We are looking for a Quality Assurance Engineer – R&D for IT Core Assets program who will work and grow within the IT Solutions, Cybersecurity & Sequencing Pre & Post-market Quality department and will report to IT Solutions, Cybersecurity & Sequencing Quality Senior Director within a team of 6 co-workers.

Responsibilities

• Lead Quality for IT, analytics, and connectivity commercial solutions: Champion quality deliverables for IT Core Assets and Connectivity, Computers & Peripherals, Knowledge base projects, ensuring compliance with applicable international standards from design to lifecycle management.
• Lead Cybersecurity quality for bioMérieux Products: Be the bioMérieux (Clinical & Industry) QA referent for cybersecurity processes related to software products.
• Lead Non-Product Software Validation strategy and implementation linked to IT Solutions & Sequencing projects
• Drive Risk Management: Design, Own and maintain Risk Management Files and facilitate risk reviews to ensure safety and usability.
• Support Post-Market Excellence: Contribute to surveillance, trend analysis, and field action processes, ensuring continuous improvement and effective cross-functional coordination within the scope.
• Advance Software Quality & Cybersecurity: Ensure software compliance (IEC 62304, 21 CFR Part 11 if applicable), support secure development, and manage vulnerabilities in collaboration with product Security team.
• Champion QMS & Best Practices: Author and review SOPs, support audits, lead CAPA and change control, and mentor colleagues to scale quality excellence.

Who are you?

• Knowledge and skills:
  • 3+ years in Quality Engineering within software environment or related roles within IVD, medical devices, biotech.
  • Advanced knowledge of standards such as ISO 13485, ISO 14971, IEC 62304, IVDR (EU 2017/746), 21 CFR Part 11.
  • Proven experience in Design Controls, Cybersecurity and risk management.
  • Nice to have: Background in Cybersecurity.
• Talents and qualities:
  • Ability to lead without direct authority, coach peers, and influence cross-functional teams globally; strong communication and negotiation skills.
  • Excellent analytical thinking, problem solving, and organization; strong written documentation skills.
  • Fluency in English and in French; ability to work in a multi-site, international environment.

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.