Medical Device Supplier Quality Engineer

Quasar Medical (Singapore) Pte Ltd; Singapore; On-site; SGD 67,000 - 100,000; Full time

Job summary

Quasar Medical (Singapore) Pte Ltd is seeking a QA/Supplier Quality professional to lead supplier quality activities. You will drive supplier assessments, audits, CAPA, and risk management across the supply chain to ensure regulatory compliance and high product quality.

The role requires strong collaboration with engineering, procurement, and manufacturing teams, with emphasis on ISO 13485 and FDA standards. Singapore-based position with potential travel.

Qualifications

• Regulatory knowledge of FDA and ISO 13485 standards.
• Excellent written and spoken English.
• Strong communication and collaboration across teams.
• Analytical and problem-solving skills; able to troubleshoot complex issues.
• Experience with supplier quality in medical devices preferred.

Responsibilities

• Evaluate suppliers for quality systems, manufacturing capabilities and compliance.
• Manage supplier risk and CAPA through supplier SCAR programme.
• Lead supplier qualification and requalification activities.
• Develop QA plans and conduct supplier audits and inspections.
• Collaborate with engineering, procurement and production to ensure compliant components.
• Prepare monthly/annual quality reports for management.

Skills

Regulatory knowledge

English proficiency

Communication skills

Analytical thinking

Cross-functional collaboration

Education

Degree in Engineering or science

Diploma in Engineering or science (5+ years experience)

Job description

Quasar Medical (Singapore) Pte Ltd is seeking a QA/Supplier Quality professional to lead supplier quality activities. You will drive supplier assessments, audits, CAPA, and risk management across the supply chain to ensure regulatory compliance and high product quality.

The role requires strong collaboration with engineering, procurement, and manufacturing teams, with emphasis on ISO 13485 and FDA standards. Singapore-based position with potential travel.