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2 часа назад

Quality Systems Team Leader (MedTech)

Формат работы
hybrid
Тип работы
fulltime
Грейд
lead
Английский
b2
Страна
Israel
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Quality Systems Team Leader (MedTech): Leading and continuously improving site quality systems for medical technologies with an accent on CAPA governance, cGMP compliance, quality agreements, and records management. Focus on coaching a multidisciplinary team, maintaining audit readiness, and implementing sustainable corrective and preventive actions in a regulated environment.

Location: Yokneam, Haifa District, Israel; hybrid

Company

Johnson & Johnson MedTech develops innovative, less invasive and personalized cardiovascular technologies for heart recovery, electrophysiology and stroke care.

What you will do

  • Lead and continuously improve site Quality System processes, including CAPA, Quality Agreements, quality training, the Quality Manual, and document and records management.
  • Manage CAPA governance through investigations, implementation plans, effectiveness checks, metrics, escalation, and timely closure.
  • Maintain procedures in line with applicable regulations, ISO standards, Quality System Regulation requirements, and company policies.
  • Govern retention schedules, Legal Hold requirements, vital records, and the lifecycle of physical and electronic records.
  • Partner with local and global stakeholders to resolve quality challenges, identify improvements, and support audit readiness.
  • Lead, coach, and develop the Quality Systems team while monitoring performance indicators and communicating risks to management.

Requirements

  • Bachelor’s degree or higher in engineering, science, quality, statistics, or a related field.
  • 2–4 years of experience leading quality assurance or Quality System activities in a regulated environment.
  • 5–7 years of working knowledge of medical-device or pharmaceutical Quality System requirements, including ISO standards and Quality System Regulation requirements.
  • Strong written and verbal English communication skills.
  • Experience leading people, projects, or cross-functional initiatives.
  • Experience with data analysis or statistical tools and quality or compliance training.

Nice to have

  • Certified Quality Engineer certification.
  • Experience with regulatory authorities, notified bodies, or external auditors.
  • Quality Lead Auditor or Certified Internal Quality Auditor qualification.

Culture & Benefits

  • Full-time hybrid work arrangement based in Yokneam, Israel.
  • Inclusive work environment focused on individual dignity, diversity, and professional contribution.
  • Opportunity to contribute to cardiovascular medical technologies and patient care.

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