Quality Engineer II — Process Excellence & Compliance

Quasar Medical (Singapore) Pte Ltd; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

Quasar Medical (Singapore) Pte Ltd seeks a Quality Assurance/Control professional to join our manufacturing operations. You will develop QA plans, monitor processes, and ensure compliance with FDA and ISO 13485 standards while supporting audits and inspections.

You will lead process improvements, handle customer quality concerns, maintain records, and train staff in quality practices, promoting a culture of continuous improvement across the organization.

Qualifications

• Degree in Engineering or science; 2-5 years progressive quality responsibility.
• Knowledge of regulatory requirements and quality standards including FDA and ISO 13485.
• Good command of English and strong analytical/problem-solving abilities.
• Able to collaborate effectively with cross-functional teams.

Responsibilities

• Develop, implement, and maintain quality assurance plans and controls.
• Monitor production processes to detect and resolve quality issues.
• Support internal and external audits and regulatory inspections.
• Investigate non-conformities and recommend corrective actions.
• Maintain documentation and traceability of quality activities.
• Train staff on quality standards and best practices.
• Approve process/product forms, risk assessments, and COA where applicable.

Skills

Regulatory knowledge

FDA regulations

ISO 13485

Analytical thinking

Cross-functional collaboration

English language

Education

Degree in Engineering or Science

Diploma in Engineering/Science with 5+ years QA experience

Job description

Quasar Medical (Singapore) Pte Ltd seeks a Quality Assurance/Control professional to join our manufacturing operations. You will develop QA plans, monitor processes, and ensure compliance with FDA and ISO 13485 standards while supporting audits and inspections.

You will lead process improvements, handle customer quality concerns, maintain records, and train staff in quality practices, promoting a culture of continuous improvement across the organization.