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4 дня назад

Digital NPD Quality Manager (MedTech)

Формат работы
hybrid
Тип работы
fulltime
Грейд
lead
Английский
c1
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
Digital NPD Quality Manager (MedTech): Leading quality and compliance activities for cloud-based and software-enabled medical device products with an accent on design controls, risk management, cybersecurity, privacy, and quality systems. Focus on maintaining Design History Files, conducting audits and CAPA investigations, supporting product releases, and mentoring Quality Engineers.

Location: Yokneam, Haifa District, Israel; hybrid work model available

Company

Johnson & Johnson MedTech develops healthcare technologies and digital solutions, including less invasive and personalized cardiovascular treatments.

What you will do

  • Lead quality and compliance activities for digital product development and New Product Development programs.
  • Ensure design control compliance across the product development lifecycle and maintain Design History Files.
  • Provide quality oversight for cloud-based and software-enabled medical device products.
  • Drive risk assessments, FMEA reviews, mitigation planning, investigations, CAPA activities, defect reviews, and issue escalation.
  • Lead quality reviews, internal audits, design reviews, product release approvals, and support external regulatory inspections.
  • Partner with R&D, Operations, external partners, and subcontractors while mentoring Quality Engineers and presenting quality metrics and risks to senior leadership.

Requirements

  • Bachelor’s degree in Engineering, Quality, Statistics, Computer Science, or a related technical field.
  • Several years of experience in Quality Engineering or Quality Management within a regulated industry, including support for NPD programs.
  • Strong understanding of design controls, risk management, and quality systems.
  • Experience working cross-functionally with R&D and Operations teams.
  • Fluent English, written and verbal, is required.
  • Strong communication, stakeholder management, analytical, leadership, and people management skills.

Nice to have

  • Medical device industry experience.
  • Experience with software, cloud-based, or digital health solutions.
  • Knowledge of cybersecurity and privacy requirements for connected medical products.
  • Experience with ISO 27001, software quality standards, audits, CAPA, and quality improvement initiatives.

Culture & Benefits

  • Hybrid work model.
  • Up to 15% domestic and international travel.
  • Opportunity to contribute to digital healthcare and cardiovascular solutions.
  • Inclusive work environment focused on innovation, quality excellence, and continuous improvement.

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