The world market leader in In vitro-Diagnostics in Rotkreuz (ZG), is looking for a quality and solutions oriented with experience in change/deviations management
Quality Assurance Manager Operations
The Operations Quality Assurance department consists of 35 persons and you will be working in a team of 10. Our team covers sensors, reagents and instruments for blood gas analysis. As a Quality Assurance Manager Operations you work with BG/E (Bloodgas & Electrolytes) Operations to ensure that company 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 regarding product care and product improvement activities as well as in all other quality aspects within the area of responsibility.
- Ensure product quality and compliance to the regulatory requirements and the proper documentation of all activities
- Quality responsibility for
- Documents: Support business partners, review and approve documents, templates and records to ensure product quality and compliance
- Change management: Support business partners, review and approve changes to ensure product quality and compliance
- Deviation management: Support business partners, review and approve deviations to ensure product quality and compliance
- Process Risks: Support business partners, review and approve pFMEA to ensure product quality and compliance
- Support special projects or initiatives in the area of quality and business partners
- Permanently optimize processes in order to increase quality and efficiency standard
- Technical or scientific degree or completed education in a technical profession.
- At least 3 years professional experience with medical device regulations including ISO 13485 and FDA regulations for the processes mentioned above
- At least 3 years professional experience with working in process improvement projects
- Solid experience with quality management
- Solid experience in a demanding interface role in a complex environment, good stakeholder management skills across all hierarchy levels to ensure a successful communication
- experience of bringing MES to production is a plus
- Very good German language skills and good English verbal and written language skills
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)
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