snr / mechanical quality engineer (design assurance) in Singapore

yit wei kwan, randstad
job type
S$ 4,300 - S$ 7,000 per month

job details

manufacturing & production
job type
working hours
S$ 4,300 - S$ 7,000 per month
5 years
reference number
yit wei kwan, randstad
add to saved jobs print

job description

about the company

My client is a producer of medical devices.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 Mechanical / Quality / Biomedical Engineering or equivalent
  • Min 5 years of experience in design and development of medical products (Class II / III)
  • Internal / Lead auditor in ISO 13485 , Quality System Regulations, Medical Device Directive will be a plus
  • In depth in the entire Design life-cycle and Phase-Gate development process
  • Ability to read technical drawings and experience in writing procedures to QMS requirements
  • Experience in manual assembly processes
  • Experience in New Product Development / Design Controls
  • Willing to work in eastern part of Singapore (Paya lebar / Enous / Ubi area)

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


product development



educational requirements

Bachelor Degree