Quality Manager (Medical Device Manufacturing)

📣 We’re Hiring: Quality Manager (Medical Device Manufacturing)

Ready to lead quality and drive continuous improvement? Join AMT Pte Ltd, a Singapore-based contract manufacturer supporting global medical device OEMs with high-precision assembly and production solutions.

📍 Location: Singapore, West Region

🏭 Environment: ISO 13485:2016-certified facility

🔎 About the role

Lead our Quality function, ensuring products and manufacturing processes meet customer requirements, applicable regulatory standards, and our Quality Management System. You’ll oversee quality across new product introduction, supplier management, production, and customer support.

🔧 Your key responsibilities

• Lead the QA/QC team across incoming, in-process, outgoing, supplier, and customer quality.

• Maintain and improve the QMS and drive audit readiness.

• Manage customer quality issues, complaints, investigations, and CAPA.

• Support NPI, product transfers, process validation, and production readiness.

• Oversee supplier quality, change control, non-conforming products, and quality documentation.

• Build a strong quality culture through training, risk assessment, and continuous improvement.

🎓 What we’re looking for

• Degree or Diploma in Mechanical Engineering, Quality, Manufacturing, or a related field.

• Typically 8–10 years of quality experience in medical device manufacturing, including 3–5 years in a supervisory or managerial role.

• Working knowledge of ISO 9001, ISO 13485, FDA QMSR (21 CFR Part 820), CAPA, risk management, validation, and audits.

• Familiarity with SPC, MSA, FMEA, DOE, 8D, 5-Why, and process capability analysis.

• Strong leadership, problem-solving, and customer-management skills, with ownership of quality issues.

• Six Sigma, CQE, Lead Auditor, or similar certification is an advantage.

🌱 Make an impact

Help shape a quality-driven manufacturing environment focused on reliable products, regulatory compliance, and operational excellence.

📩 Interested?

Send your CV to us with your current and expected salary.

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