Senior Quality Engineer (M/F)

Our client, a recognized player in the development and manufacture of high-precision medical devices, is strengthening its Quality department and is looking for an experienced Senior Quality Engineer to accompany the evolution of its Quality Management System (QMS) and support its regulated activities.

Senior Quality Engineer (M/F)

Your profile
Higher scientific or engineering education
8 to 10 years of experience in quality within medical devices
Mastery of standards and regulations: ISO 13485:2016, MDR 2017/745, 21 CFR Part 820, MDSAP
Skills in statistics, process control, and sampling plans
Very good mastery of MS-Office
English B2
Experience in eQMS and microbiology = assets
Team spirit, rigor, proactivity, excellent analytical and communication skills Your mission
You play a key role in the development, maintenance, and continuous improvement of the QMS, in direct collaboration with the Quality & Regulatory Affairs Director. You intervene in both the manufacturing part and supplier management.

Your responsibilities
Participate in the maintenance of certifications and the smooth running of the Quality department
Lead quality projects: integration of new requirements, process validation, CAPA processing
Conduct internal and supplier audits
Manage customer complaints, internal/supplier non-conformities, and control ranges
Analyze data, monitor performance indicators, and contribute to risk management
Train and sensitize employees to regulatory requirements
Collaborate closely with production and the technical department to resolve quality issues and improve processes

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