Quality Engineer Foot and Ankle
il y a 3 jours
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 in Lyon. You will be responsible for quality monitoring and the release of our Foot and Ankle products. This organization has a large supplier base 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 Lyon, France.
Key Duties and Responsibilities:
Product Quality Management:
· Manage product quality control
· Releasing finished products
· Manage product non-conformities
· Manage exemption, rework requests, corrective and preventive actions among suppliers
· Compile, analyze and communicate quality indicators
· Guide the quality inspectors in performing product inspection
Supplier Quality Management:
· Drive 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.
· Experience with supplier quality auditing
· IT literacy, experience with using Microsoft Office applications
· Passion for quality and to do things right
· Based in Lyon (FR) Area
Prefered Skills:
· Relevant Master’s degree
· 5 years’ experience in a quality assurance or a regulatory affairs role
· Certification as a lead auditor in ISO 13485
· Knowledge of ERP and quality systems, preferable Oracle and Windchill
· Strong communication skills
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