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7 дней назад

Quality Systems Expert (MedTech)

Формат работы
hybrid
Тип работы
fulltime
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 Expert (MedTech): Supporting and continuously improving quality management systems for cardiovascular medical-device operations with an accent on CAPA, quality records, training systems, and audit readiness. Focus on maintaining compliant records, supporting Agile PLM and learning-management users, and coordinating quality-process improvements in a regulated environment.

Location: Hybrid role in Yokneam, Haifa District, Israel

Company

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

What you will do

  • Support quality processes and continuous-improvement activities, including CAPA, non-product nonconformances, DRB, QSMR, ICQAs, periodic reviews, and audits.
  • Coordinate quality-systems training curricula, user groups, assignments, and training-plan updates.
  • Provide day-to-day user support for the Learning Management System and Agile PLM.
  • Maintain accurate, protected, retrievable paper and electronic records throughout their lifecycle.
  • Coordinate active and inactive record storage, offsite archiving, metadata, and archive-box tracking.
  • Partner with departments on records retention, legal holds, vital records, compliance, and process-improvement opportunities.

Requirements

  • At least 3 years of experience in a regulated quality environment.
  • Strong English skills and the ability to review technical documents in English.
  • Comfort working with computerized systems and Microsoft Office.
  • Ability to support quality management, document control, training, and audit-readiness activities.
  • Ability to work in the hybrid Yokneam, Israel setup.

Nice to have

  • Degree in engineering or life science.
  • CQE certification.
  • Experience with Agile PLM, eTQ, an LMS, or another quality system.

Culture & Benefits

  • Work in a regulated MedTech environment focused on cardiovascular healthcare innovation.
  • Collaborate cross-functionally with departments and business units across the site.
  • Contribute to continuous improvement, compliance, safety, environmental, and quality initiatives.
  • Inclusive workplace that respects individual dignity, diversity, and employee contributions.

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