Medical Device ISO13485 auditor(homebased)

BSI; Malaysia; Hybrid; MYR 70,000 - 90,000; Full time

Job summary

BSI is seeking a Medical Device Auditor to join our team in Malaysia. This role involves extensive travel across APAC to assess manufacturers’ ISO 13485 quality management systems, ensuring compliance with regulatory standards and enhancing patient safety.

Applicants should have a strong background in latex/rubber technology and a degree in a relevant field, coupled with experience in quality management systems. Fluency in English and Chinese is mandatory. Join us to make a significant impact on healthcare quality and compliance!

Qualifications

• At least 4 years of experience in medical device design, testing or manufacture.
• 2 years of experience in a Quality Management System.
• Ability to travel frequently across the APAC region.

Responsibilities

• Conduct audits at medical device manufacturers in APAC.
• Write reports and manage audit schedules.
• Advocate for the ISO 13485 APAC Delivery Team.

Skills

Background in latex/rubber technology

Fluent in English

Fluent in Chinese

Education

Degree in a relevant discipline

Job description

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.