Production Quality Engineer (CM) – Medical Devices

About the role

AMT Pte Ltd is seeking a motivated Production Quality Engineer (CM) to ensure product quality and regulatory compliance in its fast‑growing medical device manufacturing operations.

Key responsibilities

• Lead investigations of product and process non‑conformances, applying root‑cause tools such as 5 Whys, Fishbone and FMEA, and drive CAPA implementation.
• Support and execute equipment, process and test method validation (IQ/OQ/PQ) activities.
• Collaborate with production teams to maintain product conformity, accurate documentation and GMP practices.
• Improve process capability and stability through data analysis and Lean/Kaizen initiatives.
• Participate in internal and external audits, preparing quality metrics and trend reports for management.
• Ensure compliance with ISO 14971 risk management and support risk‑based decisions across production.

Required profile

• Diploma or degree in Mechanical, Biomedical, Manufacturing Engineering or related field.
• 2–5 years of experience in medical device manufacturing or other regulated industries.
• Strong knowledge of ISO 13485, GMP and FDA QMS (21 CFR 820) requirements.
• Proven ability to work cross‑functionally in a fast‑paced environment.

Required skills

• ISO 13485
• GMP
• FDA 21 CFR 820
• Validation protocols (IQ/OQ/PQ)
• Statistical analysis
• SPC (Statistical Process Control)
• MSA (Measurement System Analysis)
• FMEA
• ISO 14971 risk management
• Root‑cause analysis techniques