EPM Scientific are supporting a global, innovative and growing Medical Device company that is based in Switzerland. This company requires a Quality Assurance Manager for a 12 month contract to cover a maternity leave.
You would be required to manage a team of 3 and report directly to the Quality Director.
- Implements a quality management system to ensure that the vigilance activities are performed as per local regulatory requirement
- complaint handling and investigation process
- Responsible for the complete oversight of the day to day operations, including people management/development and provides oversight for complaint, CAPA and vigilance systems
- Collect, trend and escalate data related to Post Market Surveillance
- Responsible for the complaint files subject to review by regulatory agencies
- knowledge of applicable European and international regulatory requirements and standards, e.g. EN ISO 13485:2016, EN ISO 14971, 21CFR820, 93/42 MDD, incl. MEDDEV
- High degree of flexibility and strong inclination to work in a team
- High IT affinity, confident in using MS-Office (Excel, Word, PP,etc)
- Strong experience in the product development process, risk management and in the compliance process
- Experience in Management of the CAPA process and PMS (complaints, vigilance and Reporting, FSCA), root cause analysis and HHE