The world market leader in In-vitro Diagnostics in Rotkreuz (ZG) is looking for a highly motivated and committed Operations Quality Assurance Manager with experience in the product care of medical devices / IVDs.
Quality Assurance Manager for Consumables (80-100%)
The Operations Quality Assurance department consists of 35 people and the QA Manager will be working in a team of six, which covers the quality support of our consumables products. The QA Manager cooperates with Global Operations to ensure that the companies procedures, applicable regulations and standards (regulatory requirements of United States Food and Drug Administration, In-vitro Diagnostics Directive of the European Union, ISO 13485, etc.) are followed during manufacturing.
- Support and enable our business partners during a time of increasing production volumes and regard product care and product improvement activities as well as in all other quality aspects of our consumables products
- Ensure product quality and compliance to the regulatory requirements and the proper documentation of all activities
- Support our business partners by reviewing and approving documents, changes, deviations, reviewing and approving Q&V activities and releasing products
- Ensure improvements through CAPAs, SCARs and process updates
- Lead and/or support special projects or initiatives in the area of quality and of our business partners
- Permanently optimize processes in order to increase quality and efficiency standards
- Academic engineering or life science background
- At least 5 years of practical experience in Quality Management, Quality Assurance or Quality Control
- At least 5 years of professional experience with the medical device regulations including (ISO 13485, FDA regulations)
- First experience in leading process improvement projects and stakeholder management across all levels
- Knowledge of injection molding and SAP as a plus
- Strong communication skills in both German and English
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.