Quality Systems Specialist (6-month contract)
Our long term client, Medtronic, is specializing in medical devices and is looking for a :
- Quality Systems Specialist
- Duration : 6 months
- Location : Tolochenaz
- Is an expert for his/her Quality System(s) such as Change Control, CAPA, documentation, risk management, audit and/or training.
- Leads local and contributes to global continuous improvement initiatives to ensure his/her process performance and compliance
- Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Ensures process monitoring, reporting and improvement by providing leading KPIs.
- Trains stakeholders on his/her process.
- Participates for his/her Quality system audit and inspection preparation, resolution of audit and inspection findings.
- Collaborates with manufacturing, engineering and development functions to ensure quality standards are in place.
- Assures in his/her daily work an overall compliance to ISO 13485; 21 CFR Part 820 and EU MDR
- Bachelor’s degree required
- Minimum of 2 years of relevant experience in medical device or pharmaceutical quality, within a production site
- Fluent in French and English
- CAPA, Root Cause investigations quality tools to include DMAIC A3, 5 Whys, 6 M, Ishikawa Diagram and Pareto Charts
If that sounds interesting to you, apply now !
À propos de l'entreprise
