Medical Device ISO 13485 Auditor / Assessor (Home-based)

About the Role

Join a mission-driven organization dedicated to making a positive impact on people and the planet. As a Medical Device Auditor, you will visit medical device manufacturers throughout the APAC region to evaluate their ISO 13485 quality management systems. Your assessments help improve their performance, ensure patient safety, and maintain compliance with regulatory standards.

Onboarding and Training

• Complete comprehensive training on ISO 13485 Lead Auditor standards, Medical Device Single Audit Programme (MDSAP), and Medical Device Regulation (MDR) within the first six months.
• Begin by observing audit processes, then progress to independently conducting audits both onsite and remotely from your home workspace.

Typical Weekly Activities

• Perform audits at medical device manufacturing facilities or remotely.
• Document audit findings thoroughly and coordinate with planning teams to manage your auditing schedule.
• Continue to deepen expertise in Medical Device Regulation and actively promote the ISO 13485 standards within the APAC Delivery Team.

Candidate Profile

• Academic background in fields such as electrical engineering, computing/IT, or physics.
• Minimum of four years’ direct accountability in the design, testing, or manufacturing of active medical devices.
• Prior exposure to active medical device research and development is mandatory; software-related experience is advantageous.
• Degree in disciplines relevant to medical devices such as chemistry, physical chemistry, molecular genetics, textiles, material science, biology, biotechnology, or related fields.
• At least two years of work experience in environments with established Quality Management Systems.
• Strong familiarity with active medical devices, electrically powered products, and software life-cycle processes specific to medical devices and critical software, inclusive of regulatory and standards knowledge.
• Fluency in spoken and written English.
• Ability to be resilient and adaptable, able to travel frequently across APAC for audit assignments.
• Must be a Singapore Citizen or hold a valid Singapore Employment Pass.

Additional Information

Applicants based in Malaysia with passion for this role are warmly encouraged to apply. This position is home-based with required travel across APAC.

About the Employer

Our organization is a century-old global leader in standards and business improvement, partnering with over 77,500 clients across 195 countries and engaging a community of 15,000 experts. Our expertise spans key industries including automotive, aerospace, built environment, food, retail, and healthcare. We are committed to societal progress and sustainable development by collaborating with clients to address critical challenges from climate change to digital trust.

We are an Equal Opportunity Employer committed to diversity and inclusion in the workplace.