The world market leader in In vitro-Diagnostics in Rotkreuz (ZG) is looking for a flexible team player with strong communication skills.
Quality Assurance Manager for Qualification and Validation (60-100%)
The RDI Quality function consists of three departments: QM Systems, Design Quality Assurance and Operations Quality Assurance. You will be a team member of the Qualification & Validation Quality Team within Operations Quality Assurance.
- Provide independently quality process support for computerized system validation (CSV). Helping business partners from Development and Operations to develop a compliant validation strategy based on system and functional risk assessment, including security and data privacy requirements
- Provide independently quality process support in the area of qualification & validation (equipment, process, analytical methods) and equipment management for your assigned business partners
- Ensure sustainable compliance on site Rotkreuz Diagnostics International within area of responsibility (ISO 13485, FDA and Quality Systems Regulations)
- Enable your business partners to conduct qualification and validation activities and to create the required documentation efficiently
- Perform independent review and approval of process documents within area of responsibility (e.g. qualification plans & reports, equipment changes, all related documents to process / method / computerized system validation)
- Identify opportunities for optimization of operational procedures in order to improve quality and efficiency within area of responsibility
- Conduct training for Qualification & Validation processes and continuously monitor key performance indicators
- Technical or scientific degree or completed education in a technical profession
- At least 3 years of professional experience with quality management in relation to ISO 13485, FDA and Quality Systems Regulations
- At least 3 years of professional experience in governance of qualification and validation processes in the area of medical devices or in vitro Diagnostics
- Very good German language skills (B2 or higher) and good English verbal and written language skills
- For supporting the business partners in the different areas experiences in production areas is a plus
Please apply online. For further information about the position, please contact your Kelly recruiter, Mr. Andreas Danner, Dr. med. Dipl.-Biol. (+41 44 225 41 07/ +41 76 310 760 9)
We connect people to jobs in ways that enrich lives. Kelly Services® is a leading global provider of human resources solutions, operating in over 40 countries. Together with its subsidiaries, Kelly offers a wide range of outsourcing and consulting services; temporary, permanent and management positions as well as flexible forms of employment at all hierarchy levels. Kelly Services (Schweiz) AG has been present in Switzerland since 1979 and counts more than 200 employees in over 40 Talent Offices and Centers.