Quality Engineer: Medical Devices & Regulatory QA

Quasar Medical (Singapore) pte.ltd.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

Quasar Medical (Singapore) pte.ltd. is seeking a Quality Engineer to safeguard the quality and regulatory compliance of our medical devices throughout the manufacturing process.

You will develop QA strategies, monitor production, and support new product transfers to ensure standards are met from design to final release. The role requires 2–5 years of progressive QA responsibility in medical device manufacturing, knowledge of FDA regulations and ISO 13485, and strong analytical and communication

Qualifications

• Degree in Engineering or science with 2–5 years QA experience in medical devices.
• Knowledge of FDA regulations and ISO 13485.
• Strong English communication and teamwork skills.

Responsibilities

• Develop, implement, and maintain quality assurance plans and controls.
• Monitor production processes to detect quality issues.
• Ensure compliance with FDA, ISO 13485, and relevant standards.
• Support internal and external audits and regulatory inspections.
• Investigate non-conformities and drive corrective actions.
• Lead quality improvements and training for staff.

Skills

Quality assurance

Regulatory compliance

Analytical skills

Cross-functional collaboration

Problem-solving

Education

Engineering or science degree

Job description

Quasar Medical (Singapore) pte.ltd. is seeking a Quality Engineer to safeguard the quality and regulatory compliance of our medical devices throughout the manufacturing process.

You will develop QA strategies, monitor production, and support new product transfers to ensure standards are met from design to final release. The role requires 2–5 years of progressive QA responsibility in medical device manufacturing, knowledge of FDA regulations and ISO 13485, and strong analytical and communication