Senior Supplier Quality Engineer – Medical Device

QUASAR MEDICAL (SINGAPORE) PTE. LTD.; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

QUASAR MEDICAL (SINGAPORE) PTE. LTD. seeks a quality professional to lead supplier quality activities in a medical device setting. You will evaluate suppliers, drive corrective actions, and support audits and regulatory compliance.

Collaborating with engineering, procurement and production, you will implement containment, change control and process improvements to ensure product quality and on-time delivery.

Qualifications

• Knowledge of FDA regulations and ISO 13485 standards.
• Excellent communication skills and ability to troubleshoot.
• Strong analytical and problem-solving abilities.

Responsibilities

• Evaluate potential suppliers based on quality systems, manufacturing capabilities and compliance.
• Assess supplier performance to meet quality standards.
• Collaborate with suppliers to implement quality improvement initiatives.
• Provide technical guidance to address quality issues and drive improvements.
• Manage supplier risk including non-conformances and regulatory issues.
• Lead supplier qualification and requalification activities.
• Develop supplier QA plans, procedures and controls.
• Oversee supplier audits and inspections for compliance.
• Monitor supplier performance data to identify trends and opportunities.
• Support internal and external audits and regulatory inspections.

Skills

Supplier management

Regulatory knowledge

Communication

Analytical thinking

Cross-functional collaboration

Education

Degree in engineering or science

Diploma in engineering/science (5+ yrs exp)

Job description

QUASAR MEDICAL (SINGAPORE) PTE. LTD. seeks a quality professional to lead supplier quality activities in a medical device setting. You will evaluate suppliers, drive corrective actions, and support audits and regulatory compliance.

Collaborating with engineering, procurement and production, you will implement containment, change control and process improvements to ensure product quality and on-time delivery.