Japan medical device QMS 13485 auditor (relocation)

About the company

BSI is a total-solution company providing value-added services across management-system certification, medical-device certification, ISO-based training, standards-related information, risk-reduction tools, and standards-development services. Operating in over 180 countries with more than 81,000 clients worldwide, BSI’s UK headquarters was established in 1901 as a pioneer national standards body and remains one of the world’s oldest, now maintaining 90 offices globally.

Responsibilities

• Conduct ISO 13485 QMS audits at medical-device manufacturers across Europe, the Middle East, Africa, and occasionally the USA.
• Assess manufacturers’ compliance with ISO 13485 to improve performance, ensure patient safety, and meet regulatory requirements.
• In the first six months: complete ISO 13485 Lead Auditor, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation) training; initially observe audits, then progress to conducting them independently on-site and remotely.
• After full training: perform on-site or remote audits, write audit reports, and coordinate with the planning team to manage your audit schedule.
• Continue development in MDR and act as an advocate for the ISO 13485 EMEA Delivery Team.

Requirements

• Bachelor’s degree or higher in a science or engineering discipline (e.g., chemistry, physical chemistry, molecular genetics, textiles, material science, biology, biotechnology, or similar).
• Four or more years of direct experience in the design, testing, or manufacture of medical devices.
• At least two years of experience working in an environment with an established Quality Management System.
• Fluency in both Japanese and English (speaking and writing).
• Resilience and willingness to travel frequently across the EMEA region as required.
• For active medical devices: electrical engineering background and experience in medical-device design or development.
• For non-active medical devices: non-electrical engineering background and experience in medical-device design or development.

Preferred Qualifications

• Knowledge or experience with quality management systems.
• Completion of auditor training courses or holding auditor certification.
• Experience as an internal auditor.
• Experience in sterilization processes (highly desirable).

Desired Attributes

• Commitment to delivering excellent performance and overcoming challenges.
• Proactive in engaging with others and leading by example.
• Passion for business and ability to inspire colleagues.
• Integrity and adherence to ethical business practices.
• Customer-focused, with a drive to understand and deliver added value.

Note: BSI provides all necessary training to become an auditor.

Schedule

• Work hours: 9:00 AM – 5:30 PM (with a 60-minute break).
• Location: BSI headquarters in Minato Mirai (Yokohama); ISO 13485 auditors may work remotely after managerial approval.
• Days off: weekends, public holidays, up to 14 days of paid leave in the first year (varies by start month), and special leave for personal events.

Benefits

• Commuter allowance.
• Comprehensive social insurance coverage.
• Performance-linked bonuses.
• Annual salary review.
• Company-defined contribution pension plan (for full-time employees under 60).