QC Manager (m/f) - Medical Device
Our client is an innovative medical devices company located in Vaud region.
- Manage QC activities of incoming material and produced goods;
- Responsible for due time delivery and full compliance with procedures;
- Work on strategy to follow future demands in manufacturing activities by implementing and supervising the development of novel quality control methodologies and/or modification of existing ones;
- Lead the release of manufactured goods and plan, manage investigations on non-conforming products;
- Take the lead on new methods development to determine product specifications and control the compliance with targeted specifications;
- Participate in Design Review meetings, provide risk assessment expertise and ensure Device Master Record files are timely recorded and maintained up to date, according the Company's QMS;
- Perform internal audits and prepare reports, including propositions for corrective actions where needed, for Management;
- Support preparation and participate in external audits, as well as auditing of key suppliers.
- Education in Life Sciences with at least 5 years of relevant professional experience in Quality Control in the Medical Device industries;
- Good knowledge of bioanalytical methods commonly used in the quality control of biomolecules;
- Previous professional experience in an ISO 13485-certified environment;
- Agile and able to perform work independently and in cross-functional team projects in a fast-paced environment;
- Fluent English, knowledge of French is a plus.