senior / quality engineer (iso13485) distribution centre in Singapore

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job details

manufacturing & production
job type
working hours
s$ 4,500 - s$ 7,000 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

  • Manage the Supplier Quality metrics such Supplier Corrective Action Requests (SCAR),Corrective Action and Preventive Action (CAPA)
  • Provide suggestions to improve 3PL Quality Management System to meet Quality Agreement requirements
  • Implement and maintain Label Management Process and Over-Labeling Process at 3PL
  • Develop training and documentation materials for production
  • Implement and track Quality Hold in 3PL
  • Oversee the quality validation activitity
  • Supplier Qualification

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 / QMS
  • Experience in conducting/ leading QMS audit
  • Familiar with MDSAP (medical device audit program)
  • Experience in Good Distribution Practice (GDP) will be a plus
  • Hands on in quality inspection & failure investigation

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


quality management system


degree / diploma

educational requirements

Bachelor Degree