Quality Systems Team Leader
jj · Yokneam
תיאור המשרה
About the role
Johnson & Johnson MedTech Cardiovascular is seeking a Quality Systems Team Leader to drive compliance and quality performance for medical technologies in Yokneam, Israel. You will lead a multidisciplinary team, manage key quality processes, and partner with global functions to ensure sustainable, effective systems.
Key responsibilities
- Lead and continuously improve site Quality System processes, including CAPA, Quality Agreements, training, the Quality Manual, and document/records management.
- Manage CAPA governance, oversee investigations, implementation plans, effectiveness checks, metrics, escalation, and timely closure.
- Provide leadership for Enterprise Retention Schedule, Legal Hold preservation, and Vital Records inventory compliance.
- Partner with local and global stakeholders to resolve quality challenges, support audit readiness, and drive improvement opportunities.
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.
- Demonstrated leadership of people, projects, or cross‑functional initiatives.
Required skills
- CAPA management and governance.
- Quality Agreements development and implementation.
- cGMP training design and delivery.
- Document and records management in compliance with MD‑RIC procedures.
- Knowledge of ISO standards, Quality System Regulation, and regulatory authority interactions.
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jj
Yokneam