Medical Device ISO13485 auditor/ assessor(homebased)

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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.

In the first six months of being a Medical Device Auditor you’ll:

• 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

In a typical week after being fully trained you’ll:

• 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.

To thrive in this career, you must:

• Academic background in electrical engineering, computing/IT, or physics.

• 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

• Strong experience with active medical devices and electrically powered products (design, manufacturing, or testing), as well as software life-cycle processes specific to medical devices, health, or other critical software, including regulatory and standards experience.

• 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.