As a preferred supplier for Roche Diagnostics Int Ltd in Rotkreuz, we are looking for an individual as Quality Assurance Manager Operations, contract for one year, with extension if suitable for all parties, earliest start asap or within 3 months.
- 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 standards
- Technical or scientific degree or completed education in a technical profession.
- At Least 3 years professional experience with the medical device regulations including ISO 13485 and FDA regulations for the above mentioned processes
- 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
- Very good German language skills (B2 or higher) and good English verbal and written language skills
- experience of bringing MES to production is a plus
- Flexible and team player personality with the ability to assert yourself. You are used to working independently and are a strong communicator.
- solution oriented mindset
- self-dependent, structured, quality oriented and determined