Establishment, maintenance and management of QA system and document control according to internal and external regulatory requirements.

Customer complaint handling.

Day to day resolution of QA activity – recording, reporting, inspecting, filing, training and auditing, with a focus on subcontractor and production company auditing

Reports to          QA Manager

Responsibilities

Responsible for writing / guiding employees for writing all company procedures, instructions etc.

Maintenance of QA system.

Responsible on training system especially in quality issues

Periodic reports to Top management about Quality issues and analysis – MRB, CAPA, ECOs, internal and external audits, and product and process performance.

Participating MRB, CAPA, ECO committees.

Responsible on internal audits system.

Supplier and subcontractors approval and control over their performances.

Establishment and control of traceability system of company product.

Authorities:

Routine management of all above indicated areas.

Approval and control of company quality status using internal audit system.

Experience:

5-10 years of previous experience in the medical devices or life science QA fields managements.