medical quality engineer (npi design assurance) in Singapore

yit wei kwan, randstad
job type
S$ 5,000 - S$ 6,700 per month

job details

manufacturing & production
job type
working hours
S$ 5,000 - S$ 6,700 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

  • Participate and/or support continuous improvement initiatives
  • Manage non-conformance evaluation (NCE)
  • Assist in the completion of CAPAs
  • Conduct internal audits
  • Assembly and maintenance of Design History Files (DHF)
  • Applies Design to Cost and Design for Manufacturability methods
  • Timely follow up on Design Mitigation Review action plans and commitments
  • Ensure Risk Management (RM) files is completed and compliance with EN ISO14971:2012 standard
  • Manage Design and Development processes for NPD projects, Continuous and Sustaining projects
  • Accurate implementation of the New product development (NPD) process
  • Develop design Assurance deliverables for the project.

skills & experience required

  • Master / Bachelor Degree in Electrical / Mechanical / Quality Engineering or equivalent
  • Min 4 years of experience especially in medical device industry (class II, class III)
  • Internal / Lead auditor in ISO 13485 , Quality System Regulations, Medical Device Directive
  • Applied knowledge of ISO 14971; safety by design; Risk Management structure
  • Good understanding of IEC 62304; medical device software and IEC 62366; usability engineering will be a plus
  • Ability to read technical drawings and experience in writing procedures to QMS requirements
  • Experience in Statistical Process Tools and Reliability Methodologies
  • Experience in New Product Development / Design Controls

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


design assurance



educational requirements

Bachelor Degree