Senior Quality Engineer (M/F)

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

Your profile
Scientific or engineering higher education
8 to 10 years of quality experience in 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 command of MS Office
English B2
Experience with eQMS and microbiology = assets
Team spirit, rigour, 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 work on both the manufacturing side and supplier management.

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