Our client is an innovative medical device company settled in Canton of Vaud.
- Manage the quality strategy for a new site manufacturing site implementation and qualification;
- Lead change control strategy by reviewing requirements, specifications and technical design documents;
- Participate to validation and commissioning activities;
- Lead quality input to validation protocols, reports and investigate the causes of non-conforming activities;
- Be the Notified body main contact for audit and related support for certification;
- Interact with Management team providing quality KPIs;
- Ensure compliance with QMS for new manufacturing site;
- Participate to improve quality process.
- Bachelor's degree in Science, Engineering, Biotechnology, Quality Management;
- Justify at least a minimum of 10 years of similar experience in quality project management;
- Capacity to lead strategies for risk management, deviation, CAPA project activities;
- Relevant expertise in cGMP standards for FDA, MHRA and EU regulatory approval;
- Certification activities for new site ISO 9001 & ISO 13485.
Permanent contract - Please send us a PDF format CV #boost