Strategic Supplier Quality Engineer

Quasar Medical | Medical Device Manufacturer; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Quasar Medical is seeking a Supplier Quality Engineer (SQE) to ensure supplier quality meets our stringent standards and regulatory requirements. You will work closely with suppliers to resolve quality issues, perform audits, and implement improvements, including support for new product transfers.

You will lead supplier audits, manage CAPA programs, and drive supplier qualification activities, ensuring robust quality across the supply chain and compliance with ISO 13485 and FDA expectations.

Qualifications

• QA processes and controls
• Strong collaboration with suppliers
• Experience with audits and CAPA processes
• Familiarity with regulatory requirements (e.g., ISO 13485)

Responsibilities

• Evaluate potential suppliers based on quality systems and capabilities.
• Assess supplier performance to meet quality standards.
• Collaborate with suppliers to implement improvement initiatives.
• Provide guidance to address quality issues and drive improvement.
• Manage supplier risks and regulatory non-compliance.
• Develop risk mitigation plans to minimize impact on production.
• Maintain strong supplier relationships for collaboration.
• Communicate quality concerns and ensure mutual understanding.
• Lead supplier corrective and preventive actions (SCAR).
• Lead supplier qualification and requalification activities.
• Maintain supplier quality plans and control measures.
• Oversee supplier audits and inspections for compliance.
• Monitor supplier performance data for trends and improvements.
• Support internal and external audits and regulatory inspections.
• Investigate non-conformances and drive corrective actions.
• Participate in new product introductions to build quality in early life cycle.
• Contain non-conforming materials and implement containment strategies.
• Manage supplier change processes with minimal production impact.
• Identify opportunities for process improvements in product quality.
• Lead QA initiatives across product areas.
• Lead root cause analyses and corrective action planning.
• Support cost improvement projects.

Skills

Quality assurance

Supplier management

Audits

CAPA

Regulatory compliance

Job description

Quasar Medical is seeking a Supplier Quality Engineer (SQE) to ensure supplier quality meets our stringent standards and regulatory requirements. You will work closely with suppliers to resolve quality issues, perform audits, and implement improvements, including support for new product transfers.

You will lead supplier audits, manage CAPA programs, and drive supplier qualification activities, ensuring robust quality across the supply chain and compliance with ISO 13485 and FDA expectations.