Medical Device ISO13485 auditor assessor(homebased)

4-7 years
7 months ago 9 Applied
Job Description

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

  • 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 Malaysian language

  • Be resilient and able to meet audit delivery by travelling frequently across the APAC region as required

We're enthusiastic to receive applications from those based in Malaysia excited by this career opportunity.
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us 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 with conducting the interview virtually, please speak to a member of our recruitment team.




Job Source:

BSI continues to support our people and clients to make a difference during this challenging time. Our focus on Innovation in the way we support the COVID 19 effort, continue to deliver to clients and adapt through agile working methodologies are helping us navigate these unique times. We are still recruiting especially in areas that are Client facing and Business Development , and you can find vacancies advertised on Workday - Career - Find Jobs. We are conducting Virtual Interviews and Inductions, it's amazing how positively people are embracing new ways of working and staying connected. Stay safe. Our ambition is to be recognized and valued globally as a best-in-class company a client-driven, efficiently-run, growing business. BSI has come a long way since being founded in 1901. Today, we're a global business services organization, respected world over for the development of standards assessment of management systems testing and certification of products and services providing software solutions and the delivery of training courses. We offer diverse career paths from auditing to sales, product development to finance, and from IT to marketing.