Medical Device ISO13485 auditor assessor(homebased)

Medical Device ISO13485 Auditor Assessor (Homebased)

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Medical Device Auditor

Malaysia – 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, ensuring patient safety and compliance with regulatory procedures.

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

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

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

1. Conduct an audit on-site or remotely.
2. Write up your reports and liaise with the planning team to manage your audit schedule.
3. Continue your development of MDR and advocate for the ISO 13485 APAC Delivery Team.

To thrive in this career, you must:

1. Have 4 years or more being directly accountable for the design, testing, or manufacture of different medical devices.
2. Be degree educated in a discipline relevant to Medical Devices (e.g., chemistry, physical chemistry, molecular genetics, textiles, material science, biology, biotechnology, or similar).
3. Have at least 2 years’ experience working in an environment with an established Quality Management System.
4. Be able to speak and write fluently in English and Malaysian.
5. Be resilient and able to meet audit delivery by traveling frequently across the APAC region as required.

We’re enthusiastic to receive applications from those based in Malaysia excited by this career opportunity.

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI, helping ensure that BSI is a great place to work and a highly successful business.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.