lead auditor - iso 13485 (rm10k - rm13k) in Kuala Lumpur

kavilnd annamalai, randstad
job type
RM 120,000 - RM 156,000 per year
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job details

kuala lumpur, wilayah persekutuan
job type
working hours
RM 120,000 - RM 156,000 per year
reference number
kavilnd annamalai, randstad
apply now

job description

about the company

Randstad is partnering with Norway based company that specialisze in certification & audting. The company is expanding and they are looking for lead auditor position as part of their strategic plans.


  • Perform 3rd party onsite ISO 13485 (Medical Device) audits and MDD Technical file assessment for Singapore, Malaysia and other countries in South East Asia;
  • Schedule and plan audit activity with customers;
  • Interact directly with customers at all levels of management in developing timely, complete and accurate reports of their current level of compliance or implementation of their management system;
  • Document and report audit activities and results;
  • Provide timely and accurate reviews of customer corrective action and closure;
  • Maintains appropriate audit credentials and pursues advancement of those credentials and other related credentials as needed;

skills & experience

  • Academic qualifications such as Bachelor's Degree in Biology, Chemistry, Electrical/Electronics, Medicine or other related fields.
  • Must have a minimum of 4 years experience in the medical devices industry.
  • Must have an ISO 13485 Auditor Certification.
  • Must Have a working knowledge of ISO 13485 Codes for Active and/or Non-Active.
  • Must have a working knowledge of ISO 14971, medical device risk management.
  • Must have the ability to work independently and in teams
  • Willingness to travel and work around SEA and other locations.

culture and benefits

Aside from a highly competitive salary and, you will have access to a mobile allowance, hospital and outpatient benefits, performance bonus. You will be also exposes to regional exposures. You will also have the pleasure of working in a very friendly, close-knit team. As a large organization there is plenty of career opportunities for you to move around.

how to apply

To apply online, please click on the appropriate link. Alternatively, please send your resume to kavilnd.a@randstad.com.my (with subject title: Lead Auditor ISO 13485) or call Kavil at 03-2036 6606 if you are interested with the job.


no additional skills required


no additional qualifications required

educational requirements

Bachelor Degree