senior / quality system specialist (iso 13485) in Singapore

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job details

manufacturing & production
job type
S$ 4,100 - S$ 6,600 per month
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

  • Provide data analysis & trending of processes & products characteristics
  • Product Quality Complaint Handling -back up for complaint investigations and root cause analysis, reporting
    and trending of complaints rates
  • Manage and drive the relevant supporting functions on improvement/ preventive action activities
  • Ensure that the supporting functions adopt and apply valid quality tools / statistical methods for improvement/ preventive action activities
  • Support all new product introduction (NPI) / product transfer activities to ensure that all relevant technical procedures and requirements are met
  • Identify areas for improvement of the QMS through active participation in internal audit program
  • Support the development and administration of the complaints handling, CAPA and internal non-conformance processes
  • Management of External Quality Audits, Supplier Audit program and Customer Audit

skills & experience required

  • Master / Bachelor Degree in Electrical / Mechanical / Quality Assurance Engineering
  • Min 4 years of relevant experience in Medical Device Quality System
  • 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 manufacturing environment
  • Able to work independently with minimum supervision

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