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Quality Systems Team Leader

jj · Yokneam

New
Hybrid Senior 🇬🇧 English
Quality Agreements cGMP training ISO standards Quality System Regulation

Job description

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.

Questions fréquentes

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Source : ats:workday

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Published 1 day ago

Expires 1 month from now

7 views · 0 interested

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jj

Yokneam