- Lead and manage all aspects of Quality within the organization including a close relationship with internal and external stakeholders (subcontractors, suppliers, customers)
- Define quality goals with various teams and departments
- Initiate, monitor, and verify the effective meeting of quality targets in all areas of Company activity.
- Assure the organization complies with applicable standards and has the required certificates.
- Ensure appropriate quality plans are made and executed during all stages of the life cycle of the product.
- Ensure the promotion of awareness of applicable quality management system requirements throughout the organization.
- Report the performance of the quality management system to top management and any need for improvement in order to maintain and improve the effectiveness of the quality management system.
- Work closely with R&D, Clinical, Marketing, Regulatory, Operations, and Manufacturing to improve documentation, processes, and procedures to comply with various standards and quality requirements.
- Create, review, and approve policies, procedures, work instructions, protocols, and reports to assure compliance with standards.
- Conduct Internal audits to different teams within the organization and perform gap analysis with a plan for corrective actions.
- Conduct external audits for suppliers and subcontractors.
- In collaboration with the Regulatory Department, contacts with regulatory Notified Bodies.
- Participate in ongoing improvement of products and services.
- Initiate preventive, corrective, or improvement actions and policy as needed to assure the meeting of customer requirements and its conformance to company needs.
- Verify implementation and effectiveness of corrective actions derived from internal and external audits, complaints, and other sources of information
- Ensure that processes needed for the quality management system are documented, established, implemented, maintained, and effective
- Manage quality control (QC) personnel and activities.
Requirements
- Sc. or higher degree in engineering, computer science, or equivalent.
- Minimum 8 years experience as a Quality Manager in the medical device industry.
- Experienced in audits and communication with European notified bodies.
- Thorough knowledge related to ISO 13485, IEC 60601, and other medical devices standards and regulations.
- Strong background in development processes and methodology.
- Strong background in manufacturing processes and production line QC.
- Experience with software testing methods, tools, and environments.
- Experienced with direct management and working through matrix-management.
- Excellent verbal and written skills both in Hebrew and English.
- Experienced in writing Quality System procedures and develop appropriate training.
- Excellent data analysis, critical thinking, and problem-solving skills.
- Team player, dedicated, thorough, analytical thinker, assertive, goal-oriented.
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