Medical Device ISO13485 auditor/ assessor(homebased)

Medical Device ISO13485 Auditor/Assessor (Homebased)

Location: 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, ensuring patient safety and compliance with regulatory procedures.

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

1. Receive 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 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 of direct accountability for the design, testing, or manufacture of different medical devices.
2. Experience with Active Medical device R&D is mandatory; software experience is preferred.
3. Be degree educated in a discipline relevant to Medical Devices (e.g., chemistry, physical chemistry, molecular genetics, textiles, material science, biology, biotechnology or similar).
4. Have at least 2 years' experience working in an environment with an established Quality Management System.
5. Be fluent in speaking and writing in the English language.
6. Be resilient and able to meet audit delivery by travelling frequently across the APAC region as required.
7. Hold Singapore EP or be a Singapore citizen.

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

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI, ensuring it 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 conducting it virtually, please speak to a member of our recruitment team.