Medical Device Auditor
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Job Location:
Monthly Salary:
Posted on:
23-10-2025
Vacancies:
1 Vacancy
Job Summary
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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Key Skills
- Auditing
- Time Management
- ICD-10
- Accounting
- Component evaluation
- Workers' Compensation Law
- SOX
- Microsoft Excel
- CPT Coding
- Internal Audits
- Medicare
- Bookkeeping
