senior / medical quality management engineer (auditor iso13485) in Singapore

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job details

job category
job type
S$ 3,500 - S$ 4,800 per month
reference number
yit wei kwan, randstad
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job description

about the company

My client has presence across Asia for the medical device industry. They are seeking a QMS Engineer to lead the business in its next phase of growth.

about the job

  • Support the ongoing maintenance and certification of the QMS
  • Identify and assess the risk management framework in mitigating risk and compliance of QMS
  • Identify areas of improvements and leads project in collaboration with Quality Heads of the sites to align on and implementation of desired QMS changes
  • Lead the quality audit program in the plants
  • Management of External Quality Audits, Supplier Audit program and Customer Audit.
  • Responsible for analyzing quality indicators on the performance of QMS
  • Responsible for the further development, improvement and ongoing maintenance of QMS

skills & experience required

  • Degree / Diploma in Quality / Bioengineering / Mechanical / Electrical / Biomedical engineering or related academic
  • Min 5 years of experience in QMS audit
  • Experience in working at manufacturing plant environment will be a plus
  • Certified internal auditor in IOS13485 and / or 21 CFR Part 820 QSR
  • Knowledge in plastics / ploymer technology will be a plus
  • Exposure in MDSAP is added advantage

If you are interested in the position , kindly send your CVs in to yitwei.kwan(@)

Please include your availability, expected salary and reason for leaving current job.

We regret that only shortlisted candidates will be contacted

EA: 94C3609 / Reg: R1325913