Medical Device ISO13485 auditor assessor(homebased)

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Medical Device Assessor

Singapore homebased travel required local hire

As a Medical Device Auditor youll travel to medical device manufacturers across APAC. Youll 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 youll:

• 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 youll:

• Conduct an audit on site or remotely

• Write up your reports and liaise with the planning team to manage your audit schedule.

• Youll also continue your development of MDR and be an advocate for the ISO 13485 APAC Delivery Team.

To thrive in this career you must:

• 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.

Were 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 77500 clients in 195 countries and engages with a 15000 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.
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BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.