Medical Devices QMS Assessor(home-based)

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Medical Devices QMS Assessor (home-based)

Sector: Health and Medical
Contract Type: Permanent
Hours: Full Time

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

Job Description

As a Medical Device Auditor, you'll travel to medical device manufacturers across APAC, particularly in Indonesia. 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 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:

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:

• Have 4 or more years of direct accountability for the design, testing, or manufacture of different medical devices.
• Be degree educated in a 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 an established Quality Management System.
• Be fluent in spoken and written English and Indonesian.
• Be resilient and able to meet audit delivery by travelling frequently across the APAC region as required.
• Local hire and work from home.

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These behaviours represent how we do things at BSI and help 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.

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