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6 часов назад

Quality Supervisor, Quality & Regulatory Compliance (Orthopaedics)

Формат работы
onsite
Тип работы
fulltime
Грейд
lead
Английский
b2
Страна
Japan
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 Supervisor, Quality & Regulatory Compliance (Orthopaedics) (Medical Device Quality and Regulatory Compliance): Developing and maintaining quality management systems for the regulated orthopaedics business with an accent on regulatory compliance, document control, change management, audit management, and training management. Focus on designing simpler and more reliable QMS processes, solving stakeholder requirements, and collaborating with global partners.

Location: Chiyoda, Tokyo, Japan

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions, including products for orthopaedics and other clinical areas.

What you will do

  • Ensure compliance with applicable domestic and international regulations, standards, and quality requirements.
  • Develop and maintain an effective Quality Management System (QMS) for internal stakeholders.
  • Execute document control, change management, audit management, QMS training management, and business license management activities.
  • Develop initiatives that improve the value, efficiency, and reliability of QMS processes.
  • Identify customer needs, business requirements, and organizational changes.
  • Build trusted relationships with internal stakeholders and global partners.

Requirements

  • Knowledge and practical experience with applicable laws and QMS ministerial requirements.
  • Proactive approach with the ability to develop and implement initiatives.
  • Ability to work independently and collaboratively, with strong logical thinking, decision-making, and problem-solving skills.
  • Strong commitment to achieving goals and flexibility in execution.
  • Native verbal and written communication skills in Japanese.
  • Bachelor's degree or equivalent education; health science or a directly related field is preferred.

Nice to have

  • At least three years of experience in Quality Assurance, Vigilance Safety, Regulatory Affairs, or Quality Systems within the regulated medical device or pharmaceutical industry.
  • Business-level English.
  • Experience working in a global or cross-cultural environment.
  • IT and digital literacy.

Culture & Benefits

  • Inclusive work environment that respects employee diversity, dignity, and individual contributions.
  • The Orthopaedics business is planned to separate into a standalone company operating as DePuy Synthes.
  • Following the planned separation, employment may transfer to DePuy Synthes and be governed by its employment processes, programs, policies, and benefit plans.

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