Medical Device ISO13485 auditor / assessor(homebased)

BSI; Singapore; Hybrid; SGD 70,000 - 90,000; Full time

Job summary

A leading business improvement company is seeking a Medical Device Assessor in Singapore. The role involves conducting audits for medical device manufacturers across the APAC region and ensuring compliance with ISO 13485 standards. Candidates should have over 4 years of experience in medical devices and a relevant degree. Strong English communication skills and resilience for frequent travel are essential. Join us to make a difference and help enhance patient safety and compliance.

Qualifications

• 4+ years experience in the design, test, or manufacture of medical devices.
• Experience in working with Quality Management Systems.
• Must hold Singapore EP or be a citizen.

Responsibilities

• Conduct audits on site or remotely.
• Write reports and manage audit schedules.
• Advocate for the ISO 13485 APAC Delivery Team.

Skills

Experience with Active Medical device R&D

Fluent in English

Resilience

Education

Degree in relevant discipline (e.g., chemistry, biology)

Job description

We exist to create positive change for people and the planet. Join us and make a difference too!

Medical Device Assessor

Singapore – homebased, travel required ,local hire

As a Medical Device Auditor, you’ll travel to medical device manufacturers across APAC. You’ll help these manufacturers to improve their performance by assessing their ISO 13485 quality management system, so they can ensure patient safety and comply with regulatory procedures.

Training & Early Responsibilities

• Be given training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme) and MDR (Medical Device Regulation)
• Initially observe how audits are conducted but then grow to conduct them on an individual basis on site at medical device manufacturers across APAC and remotely from your home office

Typical Week Responsibilities

• Conduct an audit on site or remotely
• Write up your reports and liaise with the planning team to manage your audit schedule.
• You’ll also continue your development of MDR and be an advocate for the ISO 13485 APAC Delivery Team.

Qualifications

• Have 4 years or more being directly accountable for the design or test or manufacture of different medical devices
• Experience with Active Medical device R&D is mandatory, software experience is preferred.
• Be degree educated with discipline relevant to Medical Devices e.g. chemistry, physical chemistry, molecular genetics, textiles, material science, biology, biotechnology or similar
• Have at least 2 years’ experience working in an environment with a Quality Management System established
• Be able to speak and write fluently in the English language
• Be resilient and able to meet audit delivery by travelling frequently across the APAC region as required
• Hold Singapore EP or Singapore citizen required.
• We’re enthusiastic to receive applications from those based in Malaysia excited by this career opportunity.

About Us

BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.

Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.

Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.

Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between – to accelerate progress towards a better society and a sustainable world.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.