Medical Device Auditor Job at Inspire Consulting Limited, 神奈川県 横浜市

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  • Inspire Consulting Limited
  • 神奈川県 横浜市

Job Description

Job Description

Company Overview

A globally recognized certification and inspection organization is seeking a Medical Device Auditor to join its Japan-based team. The company has extensive experience in ISO 13485 certification and offers a wide range of services under international and regional standards such as EN ISO JIS Q and MDSAP. The role involves conducting audits based on medical device regulations and standards supporting clients with high-quality certification services and collaborating with cross-functional teams.

Key Responsibilities

  • Conduct audits in accordance with medical device standards and regulatory frameworks
  • Deliver certification services efficiently and professionally to clients
  • Collaborate with internal teams to ensure consistent audit quality
  • Maintain up-to-date knowledge of relevant standards and industry practices

Required Qualifications

  • Bachelors degree in a science or engineering-related field (e.g. biology chemistry biomedical engineering software engineering medicine pharmacy etc.)
  • Minimum 2 years of hands-on experience in a medical device manufacturing environment
  • Preference for candidates with experience across multiple product categories (at least 2 years per category)

Preferred Qualifications

  • Familiarity with QMS/GxP Japans Pharmaceutical and Medical Device Act (PMDA) ISO 13485/9001 MDSAP MDD MDR
  • Experience with industry associations or product certification processes
  • Strong negotiation skills with regulatory bodies
  • Experience conducting or supporting internal/external audits

Additional Skills

  • Strong analytical and problem-solving abilities
  • Effective time management and multitasking skills
  • Proficiency in Microsoft Office and other relevant systems
  • Willingness to travel (approx. 2 trips per month or 8 weeks per year)
  • English reading and writing proficiency

Benefits

  • 15 days of paid leave in the first year (granted from the start date)
  • Flextime system (core hours: 11:00 AM3:00 PM)
  • Optional defined contribution pension plan
  • Long-service recognition program
  • Paid sick leave parental leave nursing care leave and bereavement leave
  • Childcare leave and reduced working hours available
  • Tuition support for external programs (e.g. language courses)
  • Access to counseling and wellness services

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