Mission 11 months - Quality Specialist - Global Customer Service F/M/D
Marcy l'Etoile, 69, FR
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.
The Quality Specialist will support operational teams to ensure compliance with local and global regulatory requirements and corporate quality systems, with a particular focus on Complaints and Field Actions. This role provides quality expertise throughout the service lifecycle and acts as the primary quality contact for Global Customer Service.
What will be your mission ?
- Ensure compliance with all regulations and quality systems related to Complaints and Field Actions within Global Customer Service.
- Execute assigned quality projects, applying engineering principles, business standards, and project requirements, with guidance from technical quality experts as needed.
- Promote the Quality Management System (QMS) and Good Practices: draft and review procedures, support audits, manage CAPAs, and oversee change control.
- Act as the quality liaison for Global Customer Service:
- Support GCS within Franchises and Process &Analytics teams in Complaint Handling and Field Action processes.
- Manage non-conformities, deviations, and CAPAs within GCS; perform root cause analysis and follow up on action plans.
- Oversee quality documentation with GCS managers; review and approve procedures impacted by projects.
- Support operational teams in implementing change control and manage quality actions related to business transformation projects and audits.
- Monitor quality indicators (e.g., TrackWise) for process and management reviews; contribute to continuous improvement initiatives.
- Foster a culture of quality excellence across teams.
Who are you ?
- Engineer, Pharmacist, or Master’s degree in Quality with at least 3 years of experience in Quality Engineering, preferably in Pharmaceutical or Medical Device industries.
- Strong knowledge of GMP, ISO 13485, IVDR EU (2017/746), and FDA compliance.
- Proven ability to influence and collaborate across international, cross-functional teams without direct authority.
- Excellent communication and negotiation skills.
- Strong analytical, ability to solve complex quality issues and propose effective solutions.
- Proficient in technical writing.
- Fluency in English and French; comfortable working in a multi-site, international environment.
- Competence in Quality Engineering tools, techniques, and digital systems (e.g., TrackWise Digital).
- Proficiency in Microsoft Office (Excel, Word, etc.).
- Flexibility, rigor, versatility, and proactivity are essential for success.
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.