Quality Assurance Engineer II — Medical Devices

Quasar Medical (Singapore) Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Quasar Medical (Singapore) Pte Ltd is seeking a Quality Assurance professional to maintain QA plans, procedures, and control measures across manufacturing processes. The role involves monitoring production quality, supporting audits, and driving CAPA initiatives to prevent recurrence.

The ideal candidate has a degree in engineering or science with 2–5 years of QA experience in medical devices or pharma settings, and strong communication skills in English to collaborate with cross-functional

Qualifications

• Degree in Engineering or science with 2–5 years of progressive Quality responsibility.
• Regulatory knowledge including FDA and ISO 13485 is preferred.
• Strong English communication and collaboration with cross-functional teams.
• Experience in medical device or pharmaceutical manufacturing is a plus.

Responsibilities

• Develop, implement, and maintain QA plans, procedures, and controls.
• Monitor production processes to detect and resolve quality issues.
• Support audits and regulatory inspections.
• Investigate deviations; recommend corrective and preventive actions.
• Ensure timely resolution of non-conformances and traceability.
• Lead or participate in root cause analysis and cost improvement projects.
• Communicate potential process changes to customers and document changes.
• Train staff on quality standards and best practices.

Skills

Quality Assurance

Regulatory Compliance

Audits

Root Cause Analysis

Documentation

Education

Bachelor's in Engineering or Science

Diploma in Engineering or Science

Job description

Quasar Medical (Singapore) Pte Ltd is seeking a Quality Assurance professional to maintain QA plans, procedures, and control measures across manufacturing processes. The role involves monitoring production quality, supporting audits, and driving CAPA initiatives to prevent recurrence.

The ideal candidate has a degree in engineering or science with 2–5 years of QA experience in medical devices or pharma settings, and strong communication skills in English to collaborate with cross-functional