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ENOVIS

Global medical technology company; orthopedic solutions

Quality Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeRennes, FranceNo salary listedIn-person

About the Job

Responsibilities

  • Manage the quality-system documentation, including its creation, coordination, distribution, and archiving.
  • Coordinate product, process, and quality-management-system change-control activities.
  • Implement quality actions related to product, process, and system changes.
  • Participate in complaint handling and trend monitoring.
  • Process nonconformities and system corrective and preventive actions, including analysis, action definition, coordination, and implementation, and participate in associated periodic reviews.
  • Conduct initial and annual supplier quality evaluations, determine supplier approval, and monitor suppliers’ compliance with applicable quality-management-system requirements, including contracts and certifications.
  • Conduct internal and supplier audits and follow up on associated nonconformities.
  • Train personnel on quality-management-system changes and update the related training matrix.
  • Perform final product release by approving batch records.
  • Update process risk analyses and participate in product risk analyses.
  • Participate in preparing the management review.
  • Participate in carrying out the annual Quality Action Plan.
  • Manage collection and reporting of quality-management-system performance indicators and improve their measurement.
  • Prepare for and participate in external audits and inspections with the Quality Assurance supervisor, including those by notified bodies, the FDA, and ANSM; participate in corrective actions and ensure their follow-up.

About the Company

ENOVIS

Global medical technology company; orthopedic solutions

Enovis develops and sells medical devices and services to improve patient outcomes and restore mobility. Its business has two segments: Prevention & Recovery, which covers orthopedic braces, soft goods, vascular therapy, compression garments, and hot/cold therapy, and Reconstructive, which offers joint implants and minimally invasive surgical tools. The company differentiates itself with a broad, clinically focused portfolio, a global manufacturing and service network, and the Enovis Growth Excellence program to drive continuous improvement. Its goal is to deliver better patient outcomes and sustained growth by expanding its footprint and strengthening operations, including recent acquisition of LimaCorporate.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Wilmington, DE
Founded
2022

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