Quality Assurance Lead

The opportunity:

In this role, you will support manufacturing and operation with establishment and overall responsibility of QA 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:

2-4 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)