סקירה כללית
Company Description Premia Spine is revolutionizing the treatment of debilitating leg and back pain with the innovative TOPS™ System, the first-of-its-kind facet joint replacement solution. TOPS™ is the only novel non-fusion, motion preservation solution for the treatment of patients with major lumbar diseases—degenerative spondylolisthesis and spinal stenosis. Premia Spine is dedicated to developing advanced medical technologies. The TOPS™ System is designed to improve quality of life for patients, making a significant impact in the field of spinal healthcare. Role Description The Quality Assurance (QA) Director is responsible for ensuring the ongoing compliance, quality, and reliability of Premia Spine’s medical devices through oversight of production quality, design quality, and adherence to regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, MDR). The role is accountable to maintain and improve the company Quality Management System (QMS) by establishing and improving the current quality/manufacturing systems and methods to ensure the highest product quality standards. This is a full-time on-site role for a Quality Assurance Director located in the Netanya, Israel. Job Requirements: * Bachelor’s Degree or higher in Engineering, Life Science or related discipline. * Minimum 10 years of experience in medical device quality assurance, including hands-on experience in manufacturing environment. At least 5 years’ experience in QA leadership roles. * Strong knowledge and in-depth understanding of ISO 13485, FDA 21 CFR Part 820, and EU MDR quality management system requirements. * Excellent leadership, organizational, and communication skills, with a track record of driving quality improvements and team performance. * Hands-on experience managing and improving core quality system processes, including process validation, risk management, CAPA, design control, change control, and document control. * Experience with suppliers’ management and auditing, domestic and international. * Demonstrated leadership in preparing for, and successfully managing FDA inspections and EU MDR Notified Body audits. * Excellent Computational Skills, Interpersonal Skills, Certification, Industry Knowledge, Problem Solving, Critical Thinking, Presentation Skills, Product Knowledge, Leadership, Time Management, Crisis Management, Risk Management, Oral and Written Communication Skills * Proficiency in both spoken and written English. Job Description & Responsibilities: * Member of the site leadership team. * Collaborating closely with the regulatory function to ensure compliance with regulatory requirements and company quality standards, alignment with regulatory strategy, and continuous improvement across all functions. * Lead execution of company’s QA policy, while developing and executing long-term quality strategies that align with company goals, focusing on scalability, product quality, and time-to-market. * Track, trend and analyse quality data to identify systemic issues and drive required corrections and improvements. * Provide strategic oversight and governance for the development, review and maintenance of quality procedures, work instructions and related quality documentation to ensure compliance with applicable quality standards and practices. * Establish and lead quality training strategies, provide hand-on guidance and support across all functions to promote a culture of compliance and continuous improvement.
דרישות המשרה
(e.g., ISO 13485, FDA 21 CFR Part 820, MDR). The role is accountable to maintain and improve the company Quality Management System (QMS) by establishing and improving the current quality/manufacturing systems and methods to ensure the highest product quality standards. This is a full-time on-site role for a Quality Assurance Director located in the Netanya, Israel. Job Requirements: * Bachelor’s D
