Quality Systems Engineer, Medical Devices – QMS & Compliance

Quasar Medical (Singapore) pte.ltd.; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

Quasar Medical (Singapore) pte.ltd. is seeking a Quality System Engineer to drive the Quality System activities in Singapore operations, supporting new product development and transfers with emphasis on traceability and document control.

The role ensures compliance with ISO13485, GMP and FDA CFR Part 820, while collaborating across functions to strengthen quality processes and drive continuous improvement in a regulated medical device environment.

Qualifications

• Degree in Engineering or equivalent; 3–5 years of quality responsibility, preferably in medical devices.
• Excellent communication skills and strong documentation practices.
• Proficiency with FMEA, DOE, SPC and QMS/GMP writing standards.
• Knowledge of ISO9001, ISO13485, FDA 21 CFR Part 820 and medical device directives.

Responsibilities

• Support QMS processes including Non-Conformance, Internal Audit, CAPA, SCAR, Change Plan, RMA and related activities.
• Maintain quality system processes to stay compliant with quality/regulatory requirements.
• Ensure awareness of customer and regulatory requirements; develop awareness programs.
• Highlight and recommend improvements to the site QMS.
• Assist investigations and analysis of customer complaints.
• Support NPD and transfer activities from a quality system perspective.
• Assist HR with new employee induction on documentation standards.
• Support site quality projects and audits, both external and internal.
• Compile weekly/monthly site metrics and reports for management.
• Develop, revise documentation procedures and maintain all required documents.
• Train personnel on documentation standards and practices.
• Maintain compliance with ISO13485, GMP and FDA CFR Part 820.

Skills

FMEA

DOE

SPC

Quality Assurance

Regulatory knowledge

GMP

ISO13485

Education

Bachelor's degree in Engineering

Diploma in Engineering

Tools

QMS software

Job description

Quasar Medical (Singapore) pte.ltd. is seeking a Quality System Engineer to drive the Quality System activities in Singapore operations, supporting new product development and transfers with emphasis on traceability and document control.

The role ensures compliance with ISO13485, GMP and FDA CFR Part 820, while collaborating across functions to strengthen quality processes and drive continuous improvement in a regulated medical device environment.