Quality Engineer – Medical Devices & Regulatory Compliance

Quasar Medical (Singapore) Pte Ltd; Singapore; On-site; SGD 55,000 - 90,000; Full time

Job summary

Quasar Medical (Singapore) Pte Ltd is seeking a Quality Engineer to ensure quality and regulatory compliance of medical devices throughout manufacturing. You will develop QA strategies, oversee processes, and support new product transfers to embed quality early in the life cycle.

The role requires 2–5 years of progressive quality responsibility, familiarity with FDA and ISO 13485 standards, and strong analytical/problem-solving skills.

Qualifications

• Degree in Engineering or Science with 2–5 years QA experience.
• Diploma holders with >5 years QA experience may be considered.
• Knowledge of FDA regulations and ISO 13485 standards.
• Strong command of English language and communication skills.

Responsibilities

• Develop, implement, and maintain quality assurance plans and control measures.
• Monitor production processes to detect and resolve quality issues.
• Ensure compliance with regulatory requirements (FDA, ISO 13485).
• Support internal and external audits and regulatory inspections.
• Investigate deviations and non-conformities and implement CAPAs.
• Ensure timely closure of quality issues and documentation.

Skills

Analytical skills

Problem-solving

Cross-functional collaboration

English proficiency

Education

Degree in Engineering or Science

Diploma in Engineering or Science

Job description

Quasar Medical (Singapore) Pte Ltd is seeking a Quality Engineer to ensure quality and regulatory compliance of medical devices throughout manufacturing. You will develop QA strategies, oversee processes, and support new product transfers to embed quality early in the life cycle.

The role requires 2–5 years of progressive quality responsibility, familiarity with FDA and ISO 13485 standards, and strong analytical/problem-solving skills.