Senior Operational QA Engineer

CONMED Corporation; Écully; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

Un leader mondial en technologie médicale recherche un ingénieur qualité pour rejoindre son équipe dynamique. Vous serez responsable de la gestion de la qualité des produits de la société, y compris le contrôle de la qualité, la gestion des non-conformités et la supervision des audits fournisseurs. Le candidat idéal aura une formation pertinente et plusieurs années d’expérience dans un rôle d'assurance qualité, ainsi qu'une capacité à travailler dans un environnement stimulant. Rejoignez une entreprise engagée envers l'innovation et l'excellence pour contribuer à améliorer les soins aux patients.

Qualifications

• 3 ans d'expérience en assurance qualité ou affaires réglementaires.
• Compétences en communication écrite et verbale en anglais et en français.
• Expérience comme auditeur principal appréciée.

Responsabilités

• Gérer le contrôle de la qualité des produits et la documentation.
• Coordonner les audits qualité des fournisseurs.
• Analyser et communiquer les indicateurs de qualité.

Connaissances

Connaissance des normes ISO13485

Connaissance de la réglementation des dispositifs médicaux (MDR)

Compétences en communication

Formation

Bachelor en qualité ou domaine pertinent

Outils

ERP et systèmes de qualité, Oracle

Windchill

Description du poste

CONMED is a global medical technology company that specializes in the development and manufacturing of surgical devices and equipment. With a mission to empower healthcare professionals to deliver exceptional patient care, CONMED is dedicated to innovation, quality, and excellence in all aspects of our operations.

As a Quality Engineer you will be part of the CONMED Foot and Ankle Quality team. This role is responsible for quality monitoring and the release of our Foot and Ankle products. This organization has a large supplier based which needs to be managed. In this role you will be directly reporting to the Quality Manager of CONMED Foot and Ankle at our site in France.

Key Duties and Responsibilities:

Product Quality Management:

• Manage product quality control
• Manage the release of batches of finished products, including document verification
• Manage product quality documentation
• Manage product non-conformities
• Manage exemption, rework requests, corrective and preventive actions among suppliers
• Manage the quality monitoring of suppliers- Manage the preparation and monitoring of certain supplier audits
• Compile, analyze and communicate quality indicators
• Guide the quality inspectors in performing product analysis

Supplier Quality Management:

• Drive supplier Supplier Corrective Action Requests
• Manage Supplier Monitoring and ASL management
• Coordinate supplier quality audits
• Auditing key suppliers
• Participate in the selection and validation of new suppliers
• Work with R&D to design the controls on products and ensure that the necessary controls are installed
• Participate in risk assessments

Required Experience and Skills:

• Relevant Bachelor’s degree
• 3 years’ experience in a quality assurance or regulatory affairs role
• Good knowledge of ISO13485, 21CFR820, Medical Device Regulation (MDR).
• Language skills: good written and verbal English and French communications skills required.
• Based in Lyon (FR) Area

Prefered Skills:

• Relevant Master’s degree
• 5 years’ experience in a quality assurance or regulatory affairs role
• 5 years experience as a lead auditor
• Certification as a ISO13485 auditor IT literacy, experience with using Microsoft Office applications,
• Knowledge of ERP and quality systems, preferable Oracle and Windchill
• Strong communication skills
• Passion for quality and to do things right