Production Quality Engineer – CAPA, Validation & Lean

AMT PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

AMT Pte Ltd, a Singapore-based ISO 13485:2016 certified contract manufacturer, is hiring a Production Quality Engineer to lead investigations of non-conformances, drive CAPA and validate equipment and processes for medical device manufacturing.

You will partner with Production to resolve failures, analyse data, and improve process capability while supporting audits and risk management per ISO 14971. Great opportunity for hands-on quality engineers in a fast-paced setting.

Qualifications

• 2–5 years in medical device manufacturing or other regulated industry.
• Good understanding of ISO 13485, GMP and FDA QMSR.
• Experience with process validation and statistical analysis.
• Strong analytical, problem-solving and communication skills.

Responsibilities

• Lead investigations into product and process 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, analyze data and maintain 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 in accordance with ISO 14971.

Tools

FMEA

SPC

MSA

CAPA

IQ/OQ/PQ validation

Root-cause analysis

Lean Six Sigma

Data analysis

Cross-functional collaboration

Job description

AMT Pte Ltd, a Singapore-based ISO 13485:2016 certified contract manufacturer, is hiring a Production Quality Engineer to lead investigations of non-conformances, drive CAPA and validate equipment and processes for medical device manufacturing.

You will partner with Production to resolve failures, analyse data, and improve process capability while supporting audits and risk management per ISO 14971. Great opportunity for hands-on quality engineers in a fast-paced setting.