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 Engineering, 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
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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