Publié: 21 octobre 2024
Technicien Qualité / Laboratoire
Plan-les-Ouates
FREDERIQUE CONSTANT
Job description:
Quality Sr Engineer is responsible for Quality Engineering activities related to existing, introduction of new or improved products and processes into the manufacturing site, nonconformance management, and interactions with all plant functions to achieve goals and provide required manufacturing support. These includes quality assurance activities required for New Product lnitiatives (NPl), Transfer projects, Receiving, ln-Process and Finished Device Acceptance to ensure that the manufacture and distribution of medical products is in compliance with company policies and procedures, U.S. Food and Drug Administration (FDA)QSR 820 regulations, ISO 13485, ISO 14971 and the Medical Device Directive (MDD 93142 ECC) and Medical Device Regulation (MDR 20171745).
How You'll Create Impact
Participate as subject matter expert in audits by FDA, Notified Bodies, internal audit program, etc.
Ensure that Design Control and Post Market Engineering requirements are applied to Product and Process Changes and New Product lnitiatives
Required profile:
At least 3 years of practical experience in the medical device industry or other regulated industry (implantable devices experience preferred)
What we offer:
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.