Medical Device ISO13485 auditor/ assessor(homebased)

Medical Device ISO13485 Auditor/Assessor (Homebased)

Location: Singapore

Posted: 30+ Days Ago

Job Requisition ID: JR0013019

Great that you're thinking about a career with BSI!

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 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 progress to conducting 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 audits on-site or remotely.
2. Write 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. Have experience with Active Medical Device R&D (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 traveling 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, helping us 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 conducting it virtually, please speak to a member of our recruitment team.