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Open nowPosted today

Production Quality Engineer (Medical Device)

MyCareersFuture92,121 open roles

Pay
SGD 3,500 – SGD 5,000 a month
Where
Singapore
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Your applicationOpen nowProduction Quality Engineer (Medical Device)MyCareersFuture · Singapore

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Early applications get read.

8.0% of postings close within 7 days. Measured by our own scanner across the market. MyCareersFuture postings stay open a median of 3 days.

Share of postings closed within
  1. 1.6%1 day
  2. 3.6%3 days
  3. 8.0%7 days
  4. 15.0%14 days
  5. 34.2%30 days
This job: posted today

MyCareersFuture median: 3 days open

The posting

Production Quality Engineer (Medical Device) – Singapore

Singapore | Quality Engineering | Medical Devices | Manufacturing | Production | Quality Assurance| ISO13485 | ISO 14971 | IQ/OQ/PQ | GMP | FDA QMSR

Salary up to SGD 5,000/month

About the Role

A growing medical device manufacturing team in Singapore is looking for a Production Quality Engineer to support production quality, process improvement, validation, and quality management activities.

This is a hands-on role focused on investigating manufacturing issues, driving corrective actions, improving process capability, and maintaining product conformity within a regulated medical device environment. Ideal for someone who enjoys working closely with Production and Engineerin, solving practical manufacturing problems, and driving continuous improvement.

About the Company

The company is a Singapore-based contract manufacturer supporting global medical device OEMs and operates within a regulated manufacturing environment. With ISO 13485:2016 certification and strong manufacturing capabilities, the organization supports customers across production quality, process validation, quality improvement, and medical device manufacturing.

What’s in it for you

  • Hands-on exposure to medical device manufacturing and production quality
  • Work closely with Production, Engineering, and customers
  • Exposure to CAPA, validation, risk management, and quality audits
  • Develop experience with ISO 13485, GMP, and FDA QMSR requirements
  • Gain practical experience in SPC, MSA, FMEA, and root-cause analysis
  • Participate in Lean / Kaizen continuous improvement initiatives
  • Opportunity to develop a long-term career in medical device quality engineering

What you’ll be doing

  • Lead investigations into product and process non-conformances
  • Conduct root-cause analysis using 5 Whys, Fishbone, and FMEA
  • Drive CAPA and verify the effectiveness of corrective actions
  • Support IQ/OQ/PQ validation of equipment, processes, and test methods
  • Work with Production to resolve manufacturing failures and quality issues
  • Monitor process capability, stability, yield, and defect performance
  • Apply quality tools including SPC, MSA, and FMEA
  • Drive Lean / Kaizen and continuous improvement activities
  • Support internal, customer, and regulatory audits
  • Prepare quality metrics, trend analysis, and management reports
  • Support risk management activities in accordance with ISO 14971

What we’re looking for

  • Diploma or Degree in Mechanical, Biomedical, Manufacturing Engineering, or related discipline
  • Experience in medical device manufacturing or another regulated industry
  • Understanding of ISO 13485, GMP, and FDA QMSR requirements
  • Experience with process validation and manufacturing quality tools
  • Practical knowledge of CAPA, FMEA, SPC, MSA, and root-cause analysis
  • Strong analytical and problem-solving skills
  • Good communication and cross-functional collaboration skills
  • Experience with customer audits, supplier quality, or Lean Six Sigma is an advantage
  • Comfortable working closely with Production and Engineering in a fast-paced manufacturing environment
  • Able to work independently while collaborating effectively with cross-functional teams
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