Medical Device ISO 13485 Auditor
BSI
Medical Device ISO 13485 Auditor
BSI
Global standards and business improvement partner
We exist to create positive change for people and the planet. Join us and make a difference too!
Medical Device Auditor
Malaysia – 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, so they can ensure patient safety and comply 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 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:
Conduct an audit on site or remotely
Write up your reports and liaise with the planning team to manage your audit schedule.
You’ll also continue your development of MDR and be an advocate for the ISO 13485 APAC Delivery Team.
To thrive in this career, you must:
Strong background in latex/rubber technology and experience with rubber medical devices.
Have 4 years or more being directly accountable for the design or test or manufacture of different medical devices
Be degree educated with 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 a Quality Management System established
Be able to speak and write fluently in the English and Chinese.
Be resilient and able to meet audit delivery by travelling frequently across the APAC region as required
Preferably based in Kuala Lumpur.
We’re enthusiastic to receive applications from those based in Malaysia excited by this career opportunity.
About Us
BSI is a business improvement and standards company and 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 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.
BSI is a global standards and business-improvement partner that helps organizations grow by addressing society’s critical issues, from climate change to trustworthy AI. It works by developing and applying standards, certifications, training, assessment, and assurance services that enable clients to manage risk, improve governance, and demonstrate compliance. Its products operate through a worldwide network of experts, industry groups, and governments, delivering audits, certifications, and advisory guidance to help clients meet specified requirements and improve performance. What sets BSI apart is its scale and breadth: a 100-year history, a global community of 15,000 experts and 77,500+ clients across many sectors, and a collaborative approach with regulators, industry bodies, and stakeholders to implement standards in real-world operations. The company’s goal is to help clients fulfil theirs by creating trust and accelerating progress toward a fair society and a sustainable world.
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