Production Quality Engineer

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

We’re Hiring: Production Quality Engineer | Medical Device Manufacturing

Location: Singapore - West | Full-Time, Permanent

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

What you'll work on

• Lead investigations into product and process non-conformances using 5 Whys, Fishbone, FMEA and structured root-cause analysis
• Drive CAPA and ensure corrective actions are effective and sustainable
• Support IQ/OQ/PQ validation of equipment, manufacturing 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

Who you're looking for

• 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
• Experience in process validation, statistical analysis and manufacturing quality tools
• Strong analytical, problem-solving and communication skills
• Comfortable working cross-functionally in a fast-paced manufacturing environment
• Experience with customer audits, supplier quality or Lean Six Sigma will be an advantage.

Why join us ?

This is a hands-on quality engineering role where you'll work directly with Production, Engineering and customers to solve practical manufacturing challenges and improve the processes behind medical device products.

You’ll gain exposure across production quality, validation, CAPA, risk management, audits and continuous improvement - building a strong foundation for a long-term career in medical device quality and manufacturing.

What we offer

Competitive salary based on experience, performance bonus and medical benefits.