Beschreibung
Quality Assurance Engineer - ISO 13485 (English, French & German speaking required)
Our client, a leading medical device producer across Europe, are seeking an experienced Quality assurance Engineer to join their team in Zurich on an initial 6 month contract, to drive the re-certification manual/process towards ISO 13485:2016.
Duties & day to day tasks:
- Retire local Quality Manual and create/write standalone WIs, SOPs from QM content not yet covered by GQPs or Cell Therapy Quality Manual. Work closely with site team to achieve this.
- Support local QA team in preparation of ISO13485:2016 site recertification planned for Jan 2018.
- Create/write new local procedures where gaps exist regarding requirements originating from new ISO 13485:2016.
- Support site audit program and complaint management.
Requirements:
- Language skills: German, French & English
- Availability to start in June or early July
- 3-7 years experience in similar field
- Understanding/experience of ISO 13485: 2016 procedures and processes
Should you wish to receive more information, please apply by attaching your CV with your telephone number and a member of the team will reply with further information as soon as possible, usually before 14 days from receipt of application. We look forward to speaking with you.
Capital International Staffing Ltd is acting as an Employment Business in relation to this vacancy.