Senior Quality Engineer: Medical Devices & Compliance

QUASAR MEDICAL (SINGAPORE) PTE. LTD.; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

QUASAR MEDICAL (SINGAPORE) PTE. LTD. is seeking a Quality Engineer to assure quality and regulatory compliance of medical devices across manufacturing. You will develop QA strategies, oversee production processes, and support new product transfers to ensure adherence to FDA and ISO 13485 standards.

The role includes leading audits, managing non-conformities, and driving process improvements while collaborating with cross-functional teams to maintain traceability and robust documentation.

Qualifications

• Degree in Engineering or science with 2–5 years of quality responsibility.
• Regulatory knowledge including FDA and ISO 13485.
• Strong analytical and problem-solving abilities.

Responsibilities

• Develop, implement, and maintain QA plans and control measures.
• Monitor production for quality issues and drive CAPA.
• Support audits and regulatory inspections.
• Collaborate with cross-functional teams to embed quality in transfers.

Skills

Analytical thinking

Problem solving

Cross-functional collaboration

English proficiency

Education

Engineering/Science degree

Quality experience 2–5 yrs

Diploma in Engineering/Science (5+ yrs)

Job description

QUASAR MEDICAL (SINGAPORE) PTE. LTD. is seeking a Quality Engineer to assure quality and regulatory compliance of medical devices across manufacturing. You will develop QA strategies, oversee production processes, and support new product transfers to ensure adherence to FDA and ISO 13485 standards.

The role includes leading audits, managing non-conformities, and driving process improvements while collaborating with cross-functional teams to maintain traceability and robust documentation.