Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
Join us as a Engineer in Quality!
Responsabilities
Quality support for production (various production lines) and for various projects
Plan, coordinate and direct the quality aspects of process validation
Non-conformance management (initiation / evaluation / disposition on the batches / investigation)
CAPA management
Review and approve changes to documentation and processes
Work validation documentation in collaboratin with engineering (protocols, reports, process specifications, work instructions, pFMEA, master validation plan)
Provide projects updates and presentations
Quality control technical support
Participation in development and updating of procedures and other quality documents
Participation in validations of new processes (Processes, products, methods & software)
Validation of different integrated processes of Integra LifeSciences & Codman Neurosurgery
Apply and enforce GMP
Qualifications:
Minimum of 4 years’ experience in Quality Engineering area (Medical device or pharma industry experience highly preferable)
Engineering degree or equivalent
Knowledge in statistic (capability, gage RR, Anova test, control chart)
Quality knowledge in the medical industry
Organized and methodical
Outstanding communication skills with outgoing and proactive attitude
Solid organizational skills
Team spirit
Fluent in French and English
Ability to work with cross functional team (R&D, RA, manufacturing engineering, planning, production)
Proactive, rigorous, autonomous