You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for a Quality Systems Team Leader role, to join our team located in Yokneam, Israel.
Purpose: Lead the quality systems that help deliver safe, effective medical technologies.
We are looking for a Quality Systems Team Leader to lead key site Quality System processes and a multidisciplinary team. In this role, you will strengthen compliance, improve quality performance, and partner across local and global functions to ensure effective, sustainable processes.
You Will Be Responsible For
Lead and continuously improve site Quality System processes, with direct ownership of CAPA, Quality Agreements, quality training, the Quality Manual, document and records management, and related procedures.
Manage CAPA governance, including review forums, investigations, implementation plans, effectiveness checks, metrics, escalation, and timely closure.
Ensure Quality Agreements are aligned with company processes, implemented effectively, and supported by appropriate controls and subject-matter expertise.
Lead quality and cGMP training activities, strengthen compliance awareness, and coach employees and process owners on Quality System expectations.
Maintain and improve Quality System procedures in line with applicable regulations, standards, and company requirements.
Provide leadership and governance for cross-functional implementation and ongoing compliance with the J&J Enterprise Retention Schedule (ERS), Legal Hold preservation requirements, and Enterprise Vital Records (EVR) inventory.
Establish expectations, assign ownership, and monitor controls to ensure paper and electronic records are documented, stored, and maintained for validity, accuracy, completeness, consistent retrievability, and compliance with applicable MD-RIC procedures.
Oversee team execution of the physical-records lifecycle, ensuring appropriate controls for active onsite records, transfer of inactive records with required metadata, offsite archiving, and monitoring of archive-box movement.
Ensure the team understands and implements active Legal Hold Notices issued by the J&J Law Department, and monitor compliance with preservation and non-destruction requirements for applicable records, information, and copies.
Partner with local and global stakeholders to resolve quality challenges, identify improvement opportunities, and support audit readiness.
Lead, coach, and develop the Quality Systems team, building capability, accountability, and strong performance.
Monitor key performance indicators, communicate risks and opportunities to management, and drive sustainable corrective and preventive actions.
Perform other duties as assigned based on business needs.
Qualifications And Requirements
Bachelor’s degree or higher in engineering, science, quality, statistics, or a related field. – Advantage
Certified Quality Engineer (CQE) certification – Advantage
2-4 years’ Experience leading quality assurance or Quality System activities in a regulated environment. - Mandatory
5-7 years’ Working knowledge of medical-device or pharmaceutical Quality System requirements, including ISO standards and Quality System Regulation requirements. - Mandatory
Experience working with regulatory authorities, notified bodies, or external auditors. – Advantage
Demonstrated leadership of people, projects, or cross-functional initiatives. – Advantage
Strong written and verbal English communication skills. - Mandatory
Quality Lead Auditor or Certified Internal Quality Auditor qualification. – Advantage
Experience with data analysis or statistical tools. – Advantage
Experience in designing or delivering quality and compliance training. – Advantage
Required Skills
Preferred Skills:
