Quality Management System Engineer (QMS)

RECRUITPEDIA PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

RECRUITPEDIA PTE. LTD. in Singapore seeks a QMS Engineer to support and enhance the Quality Management System across multiple sites. You will ensure ISO 13485 compliance, plan internal audits, and assist with external customer and certification audits.

The role involves document control, SOP management, and driving continuous improvement with training across the organization.

Qualifications

• Diploma or Degree in Engineering or a related discipline.
• Minimum 2–3 years of QMS experience in manufacturing.
• Hands‑on experience with ISO 13485 Quality Management System is required.
• Experience in internal auditing and quality documentation is an advantage.

Responsibilities

• Maintain and improve the QMS to ensure ISO 13485 compliance and regulatory requirements.
• Plan and conduct internal audits and support external audits for customers and certifications.
• Manage document control, including SOPs, work instructions, and quality records.
• Support the implementation and validation of electronic QMS/document control systems.
• Drive continuous improvement initiatives and provide quality training across the organization.

Skills

QMS experience

Auditing

ISO 13485

Education

Engineering degree

Tools

Document control software

Job description

Our client is a leading medical device contract manufacturer with operations in Singapore, Malaysia, and China. They are looking for a QMS Engineer to support and enhance their Quality Management System across multiple sites.

Working Hours:

• Monday – Friday, 8:30am – 6:00pm

Job Responsibilities

• Maintain and improve the Quality Management System (QMS) to ensure compliance with ISO 13485 and regulatory requirements
• Plan and conduct internal audits, and support external customer and certification audits
• Manage document control, including SOPs, work instructions, and quality records
• Support the implementation and validation of electronic QMS/document control systems
• Drive continuous improvement initiatives and provide quality training across the organization

Requirements

• Diploma or Degree in Engineering or a related discipline
• Minimum 2–3 years of QMS experience in a manufacturing environment
• Hands‑on experience with ISO 13485 Quality Management System is required
• Experience in internal auditing, document control, and quality documentation is an advantage
• Strong communication, analytical, and organizational skills