Director of Quality Assurance

· Member of the Company’s management

· Reporting to the company COO

· Leading and managing all QA functions, working with cross-departmental leadership to deliver high quality products on schedule and in accordance with the company’s plan.

Main responsibilities:

• Manage, develop and maintain the Company’s Quality Management System (QMS).

· Ensure company QMS compliance with regulations and legislation, specifically FDA QSR, ISO 13485 and EU MDR Regulatory Requirements.

• Working with cross-departmental leadership to ensure that company products are developed, manufactured and
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• marketed according to the company’s SOPs.
• Continuously develop QA programs; evaluate and improve QA processes to maximize quality and efficiency.
• Manage and train the QA team.
• Develop and execute QA plans and budgets.

Requirements:

· B.Sc. in life-science or engineering.

· Experience of at least 7 years in the medical device field, out of them at least 3 years as QA manager.

· Experience in managing QA teams.

· Experience in establishment and maintenance of a QMS compliant with ISO 13485, EU MDR and FDA regulatory requirements.

· Experience in working with Notified Bodies / FDA including technical-file submissions and audits; preferably for class 3 devices.

· Good Understanding of the regulatory aspects and processes is essential.

· Wide knowledge and experience in design control including validations/qualifications, manufacturing processes validations, clean rooms, packaging and sterilization validations.

· Good technical understanding.

· Team player with excellent interpersonal relationships

· Fast and self-learner.

· Ability to work under pressure and tight schedule.

· Attention to small details.

• · Fluent in Hebrew and English