Production Quality Engineer |(Medical Device Manufacturing)

AMT Pte. Ltd.; Singapore; On-site; SGD 70,000 - 90,000; Full time

Benefits offered by this job

Medical benefits

Performance bonus

Job summary

AMT Pte Ltd, a Singapore-based ISO 13485:2016 certified contract manufacturer, is hiring a Production Quality Engineer to join the team. You will work hands-on with Production, Engineering and customers to solve manufacturing challenges and improve processes behind medical device products.

You will 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

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
• 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.

Responsibilities

• 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

Skills

Root cause analysis

CAPA

IQ/OQ/PQ

Data analysis

Quality tools

MSA

Lean Six Sigma

Audits

Process validation

Problem solving

Cross-functional teamwork

Communication skills

Education

Engineering degree

Tools

FMEA

SPC

MSA

ISO 13485

GMP

FDA QMSR

Kaizen

Job description

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

Are you a Quality Engineer who enjoys being close to production, solving real manufacturing problems and driving improvements?

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
• 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.

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.

If you’re looking to move beyond routine quality inspection and develop into a well‑rounded Quality Engineer in a regulated manufacturing environment, we’d like to hear from you.

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