QA Manager

The  technology is based on an innovative new form factor for the use of Magnetic Resonance (MRI) that enables accurate and rapid surface imaging for real-time assessment of tissue microstructure in the operating room.
The right person for this role will maintain and manage the QA system and document control according to internal and external regulatory requirements. Thus, ensuring that the company products meet the defined quality standards.
The QA manager will report to the Director of Clinical affairs.
Roles & Responsibilities:
Routine management and maintenance of QA system including:
• Document Control – Responsible for writing/guiding employees for writing all company procedures, specifications, instructions, protocols, etc. Review and approve all documentation.
• Management Review – Periodic reports to Top management about Quality issues and analysis – MRB, CAPA, ECOs, internal and external audits, and product and process performance.
• NC – Coordinator of all non-conformities, participate in NCM review board and sign off on all disposition plans and results.
• ECO – Participate in ECO committees and review and approve all implementation activities.
• CAPA – Participate in CAPA committees and review and approve all implementation activities.
• Complaints – Coordinate all complaint aspects in the company. Participate in complaints committees and review and approve all complaint investigations.
• Production support – approve work orders, support manufacturing activities, review batch records, perform a final inspection, and approve finished product release.
• Training – Coordinator of training and maintaining documentation of all training requirements, training on all quality aspects, and defining annual training plan.
• Equipment Management – Coordinator of all equipment in the company, verify calibration is performed and documented.
• Supplier Management – Subcontractors’ approval and control over their performances.
• Guiding of qualification and validation activities.
• Technical File: Responsible for establishing and maintaining technical files.
• Traceability: Establishment and control of traceability system of company product.
• Internal Audits: Establish an annual plan and verify performance.
Skills and Experience
Education: B.Sc in Engineering in one of the following fields: Quality/Biomedical/ Biotechnology/Bioscience/ or equivalent education.
Job skills:
· At least five years’ experience in QA in a medical device manufacturing company (familiarity with product development process: design, process validation, and production).
· Knowledge of relevant standards: ISO 13485:2016, MDD, 21 CFR Part 820, GMP
· High level of English
· Experience in supporting production – an advantage
· Experience with CE and FDA audits – a significant advantage
· RA experience – an advantage
Personal skills:
· Good interpersonal and relationship skills
· Attention to detail/self-directed
· Ability to operate effectively in a fast-changing environment
· Problem solver, resourceful, motivated, team player, mission-oriented, strive for excellence.