Hands-On Production Quality Engineer – Medical Devices

AMT Pte. Ltd.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Benefits offered by this job

Performance bonus

Medical benefits

Job summary

AMT Pte Ltd, a Singapore-based ISO 13485:2016 certified contract manufacturer serving global medical device OEMs, is looking for a Production Quality Engineer to join our team.

This hands-on role works directly with Production, Engineering and customers to solve practical manufacturing challenges and improve processes behind medical device products, while driving CAPA, risk management and continuous improvement in a regulated environment.

Qualifications

• Diploma/Degree in Mechanical, Biomedical, Manufacturing Engineering or related discipline.
• 2–5 years' experience in medical device manufacturing or another regulated industry.
• Good understanding of ISO 13485, GMP and FDA QMSR requirements.

Responsibilities

• Lead investigations into non-conformances using 5 Whys, Fishbone, FMEA and root-cause analysis.
• Drive CAPA and ensure corrective actions are effective and sustainable.
• Support IQ/OQ/PQ validation of equipment, processes and test methods.
• Partner with Production to resolve failures and monitor product conformity.
• Monitor and improve process capability, stability, yield and defect performance.
• Apply quality tools including SPC, MSA and FMEA.
• Drive continuous improvement and Lean/Kaizen initiatives.
• Support internal, customer and regulatory audits.
• Prepare quality metrics, trend analysis and management reports.
• Support risk management activities per ISO 14971.

Skills

Root-cause analysis

FMEA

Fishbone

5 Whys

Education

Engineering degree (Mechanical/Biomedical/Manufacturing)

Tools

SPC

MSA

Job description

AMT Pte Ltd, a Singapore-based ISO 13485:2016 certified contract manufacturer serving global medical device OEMs, is looking for a Production Quality Engineer to join our team.

This hands-on role works directly with Production, Engineering and customers to solve practical manufacturing challenges and improve processes behind medical device products, while driving CAPA, risk management and continuous improvement in a regulated environment.