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
Bachelor’s 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, Japan’s 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 AM–3:00 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