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

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

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