Calling all QA Managers, this is a unique opportunity to make real change within the medical device field.
I'm working with a client in Switzerland who is based within the Medical Device field. You will be closely working with the CEO and senior management to make real change in a company who pride themselves on innovation, quality and excellence.
Responsibilities -
• Maintaining, implementing and monitoring Quality Management System in line with company standards, ISO 13485 and other medical device standards.
• Planning internal and external audits
• Training workforce to raise awareness and compliance with quality standards.
• Dealing with QM processes such as - internal and external NC/deviations, CAPA and customer complaints.
• Participation in CAPA when deviations occur and then implementing improvement measures.
Requirements -
• Degree level - in Natural Sciences, Engineering or similar fields.
• 2 years within Quality in the Medical Device field
• Spoken and written German... and English - to a high level
• Experience in auditing and certification processes
• Knowledge and experience in implementing quality standards such as - ISO 13485
Desired skills -
Experience with FDA regulation
St Gallen Switzerland