Quality Manager

AMT Pte. Ltd.; Singapore; On-site; SGD 110,000 - 170,000; Full time

Job summary

AMT Pte Ltd in Singapore is seeking a Quality Manager to lead the Quality function in a medical device manufacturing setting. You will ensure products and processes meet customer requirements and regulatory standards, and you will drive the QMS, audits, and CAPA across the organization.

You will oversee supplier quality, NPI support, product transfers, and production readiness while building a culture of quality through training, risk assessment, and continuous improvement.

Qualifications

• 8–10 years of quality experience in medical device manufacturing

Responsibilities

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

Skills

Leadership

Problem-solving

Customer management

Quality ownership

Education

Degree or Diploma in Mechanical Engineering/Quality/Manufacturing

Tools

SPC

MSA

FMEA

DOE

8D

5-Why

Process capability analysis

Job description

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.

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.

• 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.

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