medical supplier / quality engineer (vendor audit & fai) in Singapore

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job details

manufacturing & production
job type
working hours
s$ 4,100 - s$ 5,800 per month
5 years
reference number
yit wei kwan, randstad
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job description

about the company

My client is an US MNC.They offers a comprehensive range of analytical system solutions, software, and services for scientists. They are a leading analytical laboratory instrument manufacturing in the industry. The business succeeds on the speed of its innovation and there are great opportunities to progress in this dynamic company.

about the job

  • Oversight the overall validation (IQ/OQ/PQ) activities
  • Supplier Qualification
  • Support in Supplier Audit Program
  • Develop and Maintain inspection plan and procedures for incoming materials and Finished Goods
  • Implement and track Quality Hold in 3PL
  • Lead failure investigation and QI project
  • Implement and maintain Product Inspection Process and Product Release Process

skills & experience required

  • Master / Bachelor Degree in Electrical / Mechanical / Quality Assurance Engineering or equivalent
  • Min 4 years of relevant experience in medical device manufacturing environment
  • Internal / Lead auditor in ISO 13485 / 21 CFR 820
  • Sound knowledge of FDA Quality System Regulations
  • Familiar with MDSAP (medical device audit program)
  • Experience in Good Distribution Practice (GDP) will be a plus
  • Hands on in quality inspection & failure investigation / vendor audit & FAI related
  • Willing to work in eastern part of Singapore (Changi)

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


vendor quality audit


Degree / Diploma

educational requirements

Bachelor Degree