Production Quality Engineer (Medical Device)

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

Benefits offered by this job

Medical benefits

Performance bonus

Job summary

AMT Pte Ltd in Singapore is seeking a Production Quality Engineer to join our medical device manufacturing team. You will lead investigations into product and process non-conformances, drive CAPA effectiveness and support IQ/OQ/PQ validation of equipment and methods.

This role requires 2–5 years in medical device manufacturing or a regulated industry, with strong knowledge of ISO 13485, GMP and FDA QMSR, plus experience in process validation and SPC/FMEA, and solid communication skills for

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

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, 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

Analytical thinking

Communication

Cross-functional collaboration

Education

Degree in Mechanical/Biomedical/Manufacturing Eng

Tools

5 Whys

Fishbone (Ishikawa)

FMEA

SPC

MSA

Job description

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

Singapore – West | Full-Time, Permanent

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

Who we’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.