Quality Manager (Medical Device Manufacturing)

AMT PTE. LTD.; Singapore; On-site; SGD 120,000 - 160,000; Full time

Job summary

AMT Pte Ltd, a Singapore-based contract manufacturer serving global medical device OEMs, is seeking a Quality Manager to lead the quality function and ensure compliance across products and processes.

You will oversee QA/QC across NPI, supplier quality, production, and customer support, driving continuous improvement and audit readiness in a regulated environment.

Qualifications

• Degree or Diploma in Mechanical Engineering, Quality, or Manufacturing.
• 8–10 years of quality experience in medical device manufacturing, with 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.

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.

Skills

Leadership

Quality management

Problem-solving

Customer management

Regulatory knowledge

Education

Degree or Diploma in Mechanical Engineering, Quality, Manufacturing

Job description

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.