Neurolief Ltd Company Logo Netanya, Israel

QA Manager

  • Full Time
  • Netanya, Israel
  • Applications have closed

 

QA Manager

Netanya, Israel ·  Fulltime

 

  • 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.

 

Please click here to apply.

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