Quality Compliance Manager (M/F)
Job Description:
You will take charge of a set of quality and regulatory activities, with the objective of guaranteeing product compliance, supplier control, and the robustness of the quality system.
- Regulatory Quality and Certifications
Ensure exchanges with Notified Bodies and competent authorities for obtaining and maintaining CE certificates for products,
ISO 13485 certificates and MDR compliance,
certifications applicable to resale products, subcontractors, and the site.
Participate in the preparation and hosting of certification audits.
- Management of Product, Supplier, and Subcontractor Quality
Lead the management of non-conformities, CAPA, and change controls within the scope of resale products, subcontractors, and the site.
Conduct investigations related to quality events and ensure the follow-up of associated action plans.
Update and deploy control plans applicable to resale products and subcontracted activities.
Write and update quality specifications for suppliers and subcontractors.
Organize and lead supplier audits, as well as the follow-up of resulting corrective actions.
- Customer Quality and Vigilance
Manage customer complaints related to resale products and subcontracted products.
Ensure materiovigilance activities for the concerned products, as well as for products manufactured on-site.
Lead product recalls, safety notices, and any necessary field actions.
- Quality Management System
Participate in the document management of the quality system: procedures, instructions, forms, and records.
Plan, prepare, and conduct internal audits.
Contribute to the maintenance and continuous improvement of the QMS across the entire assigned scope.
Profile Description:
With a Master's degree (Bac+5) in the field of quality or equivalent, you have a minimum of 3 years of experience.
Confirmed experience of at least 3 to 5 years in a quality function, ideally in the medical device, healthcare, or a highly regulated industrial environment sector.
Significant experience in supplier quality, customer quality, non-conformity/CAPA management, audits, and materiovigilance. Good mastery of ISO 13485 standards.
Knowledge of relations with Notified Bodies and competent authorities.
Mastery of quality tools: NC, CAPA, change control, audit, document management, complaints, vigilance.
Ability to work on cross-functional topics combining product, supplier, regulation, and quality system.
Good writing skills and ease in exchanges with internal and external stakeholders.
Fluent English is imperative.