Senior / Engineer, Production Quality

About the company

AMT Pte Ltd (AMTPL) is a subsidiary of Advanced MedTech Holdings, a wholly owned subsidiary of Temasek Holdings.

AMTPL was established in 1990 and headquartered in Tuas, Singapore. As a hypergrowth, leading contract manufacturing company with 17% CAGR over last 7 years, we provide end-to-end medical device development and manufacturing services to our worldwide customers, by offering total solutions throughout the conceptual to mass production phase for the medical, automotive, industrial and electronic sectors.

Utilizing over 35 years of expertise and capabilities in metal injection molding (MIM), precision machining, mold fabrication, 3D metals printing and medical device assembly, AMTPL serves our global partners from ideation to product commercialization.

We are looking for a motivated Engineer, Production Quality (Medical Device) to join our team and manage our product quality.

About the Role

Key Responsibilities:

• Nonconformance & CAPA Management - Lead investigations for product or process non‑conformances, perform structured root‑cause analysis (5 Whys, Fishbone, FMEA), and implement effective corrective and preventive actions.

• Process Validation - Support and execute validation activities (IQ/OQ/PQ) for equipment, manufacturing processes, and test methods.

• Production Quality Support - Work closely with Production team to maintain product conformity, ensure documentation accuracy, and uphold Good Manufacturing Practices. And Support Production in failure, data and root cause analysis.

• Process Capability & Improvement - Collaborate with engineering and production teams to enhance process stability, capability, and control.

• Continuous Improvement - Drive initiatives to reduce defects, improve yield, strengthen operator awareness, and support Lean/Kaizen activities.

• Audit Participation - Contribute to internal audits and support external audits conducted by customers, notified bodies, and regulatory authorities.

• Quality Reporting - Prepare quality metrics, trend analyses, and reports for management review.

• Risk Management - Ensure compliance with ISO 14971 risk management processes and support risk‑based decision making across production activities.

Qualifications:

Diploma or Degree in Engineering (Mechanical, Biomedical, Manufacturing, or related field).

Minimum 2–5 years of experience in medical device manufacturing or other regulated industries.

Required Skills:

• Strong understanding of ISO 13485, GMP, and FDA QMSR (21 CFR Part 820) requirements.

• Experience with validation protocols, statistical analysis, and quality tools (SPC, MSA, FMEA).

• Excellent analytical, problem‑solving, and communication skills.

• Ability to work cross‑functionally and manage multiple priorities in a fast‑paced environment.

Preferred Skills:

Advantageous: Experience with customer audits, supplier quality, or Lean/Six Sigma certifications.

Join us if you like working in a team-oriented atmosphere that encourages innovation, knowledge-sharing, and professional development.

Please indicate your current & expected salary in your CV.