medical device quality engineer (iso13485) in Singapore

posted
contact
yit wei kwan, randstad
job type
permanent
salary
S$ 2,800 - S$ 4,200 per month

job details

posted
location
singapore
specialism
manufacturing & production
job type
permanent
working hours
Full-Time
salary
S$ 2,800 - S$ 4,200 per month
experience
4 years
reference number
91M0152420_1612715207
contact
yit wei kwan, randstad
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job description

about the company

Our client designs, manufactures equipment and materials in the medical devices industry. They have the people and ethos to act with speed, innovation, enterprise and creativity. The scope of the offer, the size of the business, the autonomoy to drive your career forward all adds up to a great place to work.

about the job

  • Quality Management Systems (QMS) implementation and maintenance
  • Support product transfer activities
  • Perform Monthly Quality Data Analysis as input for the Site Quality Management Review
  • Manage supplier quality matters (Audit / Nonconformance / Change Management)
  • Plan and execution of both internal audits and external audits
  • Conducting quality awareness training
  • Develop the training material for QMS
  • Plan, test and qualify quality-related software changes and updates
  • Analyse quality data
  • Creation of Inspection plan in SAP

skills & experience required

  • Degree / Diploma in bioengineering / quality / electrical / mechanical engineering or equivalent
  • Min 3 years of experience in regulated / manufacturing / clean-room environment
  • Quality Inspections techniques and experiences in handling measuring instruments
  • Know-how of QMS regulations: ISO 13485, 21 CFR 820, ISO 14971, MDD, AIMD, applicable local regulations
  • Internal auditor - ISO13485 certification
  • Able to read technical drawings
  • Experience as lead/auditee in third party audits
  • SAP and Success Factor User experience is a plus
  • Willing to work in Ubi / Macpherson area

If you are interested in the position , kindly send your CVs in to yitwei.kwan(@)randstad.com.sg

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

skills

13485

qualification

degree

educational requirements

Associate Degree/Diploma