QA Specialist - Night shift (BBBH451714) Vaud, Suisse
For our client specialized in medical devices, localized in the French part of Switzerland, we are looking for a :
QA Specialist – Night shift
Your responsibilities
- Guarantee the application of ISO13485 norms, 21CFR part 820 and other applicable regulations
- Ensure conformity of good manufacturing practices and internal QMS
- Support and manage quality events related to production operations (incident report, non-conformances)
- Participate to investigations to identify root cause and to product impact analysis
- Define corrections, corrective and preventive actions to prevent reoccurrence of events and support for implementation in production
- Identify possibility for improvements for production processes and for related documentation
- Ensure follow-up of his activities and provide KPIs
- Ensure training steps related to your scope of activities
- Contribute to quality assurance documentation (release documents, records) related to your scope of activities
- Participate to continuous improvement and pro-actively adopt a solution-based approach
- Prepare and support QA Team during audits & inspections
- Ensure back up of other QA Team members
- Support and promote the diffusion of a high-quality mindset in the company
Your profile
- Scientific education
- Professional experience in Quality Assurance for Medical Devices
- Knowledge of the main Quality System Management regulations for Medical Devices (21 CFR part 820 & ISO13485) and GMP environment
- Professional experience in Medical Device Company having a production environment
- Fluent in French,
- Basis in German and/or English
Your application Please apply on-line. For more information, contact Ms Sophie Darthenay