Production Quality Engineer - Medical Devices, CAPA

AMT Pte. Ltd.; Singapore; Sur place; SGD 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Medical benefits

Performance bonus

Résumé du poste

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.

Responsabilités

• 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

Connaissances

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

Formation

Engineering degree

Outils

FMEA

SPC

MSA

ISO 13485

GMP

FDA QMSR

Kaizen

Description du poste

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