Quality Systems Team Leader

About the role

Johnson & Johnson MedTech Cardiovascular is seeking a Quality Systems Team Leader to lead site quality system processes and a multidisciplinary team in Yokneam, Israel. The role focuses on strengthening compliance, improving quality performance, and partnering with local and global functions.

Key responsibilities

• Lead and continuously improve site Quality System processes, including CAPA, Quality Agreements, training, the Quality Manual, and document management.
• Manage CAPA governance, investigations, implementation plans, effectiveness checks, metrics, escalation, and timely closure.
• Ensure compliance with J&J Enterprise Retention Schedule, Legal Hold preservation, and Enterprise Vital Records inventory.
• Partner with stakeholders to resolve quality challenges, identify improvement opportunities, and support audit readiness.
• Lead, coach, and develop the Quality Systems team, monitoring KPIs and driving corrective actions.

Required profile

• Bachelor’s degree or higher in engineering, science, quality, statistics, or related field.
• 2-4 years experience leading quality assurance or Quality System activities in a regulated environment.
• 5-7 years working knowledge of medical‑device or pharmaceutical Quality System requirements, including ISO standards and QSR.
• Experience interacting with regulatory authorities, notified bodies, or external auditors.
• Strong written and verbal English communication skills.

Required skills

• CAPA management
• cGMP knowledge
• ISO standards and Quality System Regulation compliance
• Legal Hold and records retention processes
• Data analysis and statistical tools (advantage)