Medical Devices QMS Assessor(home-based)

Medical Devices QMS Assessor (home-based)

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Job Description

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

• 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 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:

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

To thrive in this career, you must:

• Have more than 4 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 of experience working in an environment with an established Quality Management System.
• Be able to speak and write fluently in English and Indonesian.
• Be resilient and able to meet audit delivery by traveling frequently across the APAC region as required.
• Be a local hire and work from home.

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

About Us

BSI is a business improvement and standards company. 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 77,500 clients in 195 countries and engages with a 15,000-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 fulfill theirs.
BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues—from climate change to building trust in digital transformation and everything in between—to accelerate progress towards a better society and a sustainable world.