Medical Device ISO13485 auditor assessor(homebased)

Overview

Medical Device ISO13485 auditor assessor (homebased) – BSI WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Responsibilities

• As a Medical Device Auditor, you’ll travel to medical device manufacturers across APAC to assess their ISO 13485 quality management system, ensuring patient safety and regulatory compliance.
• During the first six months, you’ll receive training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
• Initially observe how audits are conducted, then perform audits on an individual basis on site at medical device manufacturers across APAC and remotely from your home office.
• In a typical week after full training, conduct audits on site or remotely, write up reports, and liaise with the planning team to manage your audit schedule.
• Continue your MDR development and be an advocate for the ISO 13485 APAC Delivery Team.

To Thrive In This Career

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. BSI delivers on its purpose by helping its clients fulfil theirs.

Living by our core values of Client-Centricity, Agility, and Collaboration, 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. BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.

Details

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