Production Quality Engineer (Medical Device)

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