QA Leader

The opportunity:

This position is initially to cover maternity leave, with a very strong possibility of continuation after the original employee returns. In this role, you will support manufacturing and operation with establishment and overall responsibility of Change Control processes.

In this position you will be asked to:

• Maintain the QMS to fulfill quality and regulatory requirements:
• Authors new or revised site procedures as assigned.
• Assures compliance of local QMS procedure and updates as required.
• Maintains the effectiveness of the QMS in accordance with the company objectives and applicable requirements
• Executes QA activities in line with defined procedures and processes: CAPA non-conformities, training, document control
• Ensures that all suppliers used by the company are selected, evaluated and re-evaluated and that records of this assessment are maintained.
• Ensures quality records are established and maintained to provide evidence of the QMS effectiveness.
• Review, edit and approve change controls, work-instructions, reports and other documentation.

A successful candidate will have the following qualifications:

· 4-5 years’ related experience in a medical device company

• Experience and knowledge with standards and regulations (MDR 2017/745, ISO 13485, FDA QSR)
• Experience with statistical techniques, risk analysis
• Excellent English language skills (verbal and writing)
• Relevant degree (e.g., biomedical engineering or related science / technical discipline)

Bonus Points:

• CQE and process validation knowledge
• Experience with Class III implantable medical devices
• Experience with working in controlled environment (clean room)