Quality Systems Engineer II, QMS & Compliance

Quasar Medical; Singapore; Hybrid; SGD 60,000 - 90,000; Full time

Job summary

Quasar Medical Singapore is seeking a Quality System Engineer to oversee QMS activities, support new product development and transfers, and ensure traceability and compliance of quality documents and records.

The role requires 3–5 years in medical device quality, proficiency in FMEA/DOE/SPC, and knowledge of ISO9001/ISO13485 and FDA 21 CFR Part 820. Strong communication and coordination with HR and site management are essential.

Qualifications

• Degree in Engineering or equivalent; 3-5 years quality experience.
• Diploma in Engineering or equivalent with 5+ years experience.

Responsibilities

• Support QMS, Non-Conformance, Internal Audit, Complaints handling, CAPA, SCAR, Change Plan, RMA.
• Maintain and ensure compliance with ISO9001, ISO13485, FDA CFR Part 820 requirements.
• Assist in external customer and quality system audits; prepare site metrics.

Skills

FMEA

DOE

SPC

Communication

Education

Degree in Engineering or equivalent

Diploma in Engineering or equivalent

Job description

Quasar Medical Singapore is seeking a Quality System Engineer to oversee QMS activities, support new product development and transfers, and ensure traceability and compliance of quality documents and records.

The role requires 3–5 years in medical device quality, proficiency in FMEA/DOE/SPC, and knowledge of ISO9001/ISO13485 and FDA 21 CFR Part 820. Strong communication and coordination with HR and site management are essential.