Medical Device ISO 13485 Auditor (Home-Based)

About the role

BSI is hiring a Medical Device Assessor (ISO 13485 auditor) based in Singapore, working from home with travel required. You will travel to medical device manufacturers across APAC and help them improve their performance by assessing their ISO 13485 quality management systems, so they can ensure patient safety and comply with regulatory procedures.

Key responsibilities

• In the first six months, receive training in ISO 13485 Lead Auditor, MDSAP and MDR
• Initially observe audits, then conduct them individually on site at manufacturers across APAC and remotely from your home office
• After full training, conduct audits on site or remotely and write up reports
• Liaise with the planning team to manage your audit schedule
• Continue developing MDR knowledge and act as an advocate for the ISO 13485 APAC Delivery Team

Required profile

• Academic background in electrical engineering, computing/IT or physics
• Degree in a discipline relevant to medical devices (e.g. chemistry, biology, biotechnology, material science)
• At least 4 years directly accountable for the design, test or manufacture of medical devices
• Active medical device R&D experience is mandatory; software experience is preferred
• At least 2 years in an environment with an established Quality Management System
• Strong experience with active medical devices and electrically powered products, and with software life-cycle processes for medical devices, including regulatory and standards experience
• Fluent spoken and written English
• Resilient and able to travel frequently across APAC
• Singapore EP or Singapore citizenship required; applicants based in Malaysia are welcome