CQ Specialist QMS/Complaints - France

The Commercial Quality Specialist, QMS/Complaints – France supports quality management system (QMS) and complaint‑handling activities for commercial operations within the French market. This role helps ensure compliance with applicable regulatory requirements, quality standards, and internal procedures, with a strong focus on post‑market quality processes. The position plays an important role in protecting patient safety, maintaining regulatory compliance, and supporting business continuity while partnering closely with Commercial, Regulatory Affairs, and Supply Chain teams.

Key Responsibilities

• Support commercial quality activities related to QMS and complaints, ensuring compliance with regulatory requirements and internal quality standards.

• Manage and support complaint handling processes, including documentation, investigation support, and timely closure.

• Assist with post‑market surveillance activities, including adverse event reporting and field action support as required.

• Support implementation and maintenance of QMS procedures, records, and controls within the local market.

• Partner with Commercial, Regulatory Affairs, and Supply Chain teams to support compliant product distribution and lifecycle activities.

• Participate in internal audits, external audits, and health authority inspections as required.

• Monitor quality issues, trends, and metrics related to complaints and QMS and support corrective and preventive actions.

• Maintain accurate quality documentation and reports related to commercial quality activities.

Qualifications

Education:

• Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or a related discipline (required).

• Advanced degree in a scientific, quality, or regulatory field (preferred).

Experience and Skills:

Required:

• Typically 2-4 years of experience in Quality, Regulatory, or Compliance roles within a regulated industry.

• Experience supporting QMS and complaint‑handling processes.

• Foundational understanding of quality system requirements and regulatory expectations for commercial operations.

• Experience supporting post‑market surveillance activities, audits, or inspections.

• Strong attention to detail, documentation, and organizational skills.

• Effective communication and cross‑functional collaboration skills.

Preferred:

• Experience in medical devices, healthcare, or other highly regulated industries.

• Familiarity with EU MDR and French regulatory requirements (e.g., ANSM).

• Experience working in a multinational or matrixed organization.

• Exposure to health authority interactions or regulatory inspections.

• Quality or Regulatory certifications (e.g., ASQ, RAC).

Other:

• Language: French required; English proficiency preferred.

• Travel: Limited; occasional domestic travel within France.

• Certifications: Quality or Regulatory certifications preferred but not required.

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