2 часа назад
Quality Systems Team Leader (MedTech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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