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

The Supplier Quality Engineer (SQE) will be responsible for ensuring that our suppliers meet our quality standards and requirements. This role involves working closely with suppliers to resolve quality issues, performing audits, and implementing improvements to ensure that our products and processes maintain high standards of quality and reliability. This will include support for new product transfers.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Conduct thorough evaluations of potential suppliers based on quality systems, manufacturing capabilities, and compliance history.
• Assess supplier performance and capabilities to ensure they meet or exceed company quality standards.
• Collaborate with suppliers to identify and implement improvement initiatives to enhance quality and efficiency.
• Provide technical guidance and support to suppliers to address quality issues and drive continuous improvement.
• Assess and manage supplier risks, including supply chain disruptions, quality deficiencies, and regulatory non-compliance.
• Develop and implement risk mitigation plans to minimize potential negative impacts.
• Build and maintain strong relationships with suppliers to foster collaboration and trust.
• Communicate effectively with suppliers to address quality concerns and ensure mutual understanding.
• Drive all supplier corrective and preventive action through supplier SCAR programme in a timely manner to ensure robust and effective action are in place.
• Lead and drive all supplier qualification and requalification activities

Quality Assurance and Control:

• Develop, implement, and maintain supplier quality assurance plans, procedures, and control measures.
• Conduct or oversee supplier audits and inspections to verify compliance with quality standards and regulatory requirements.
• Monitor and analyze supplier performance data to identify trends and areas for improvement.
• Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, and other applicable standards.
• Support internal and external audits and regulatory inspections.
• Investigate and resolve supplied material-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.
• Ensure the non-conformance or quality issue is resolved and complete in a timely manner.
• Participate in new product introductions to ensure quality is built into all products early in their life cycle
• Investigate and resolve non-conforming materials from suppliers, including root cause analysis and corrective actions.
• Implement effective containment strategies to prevent the release of defective products.
• Manage the supplier change process and ensure the implementation of the change has minimum impact to the production.
• Identify opportunities for process improvements to enhance product quality and manufacturing efficiency.
• Lead and drive QA initiatives across the product areas
• Lead or participate in root cause analysis and corrective action planning.
• Support and drive cost improvement project

Documentation and Reporting:

• Prepare and support monthly / annual quality reports to management and other stakeholders.
• Ensure proper documentation and traceability throughout the manufacturing process.

Collaborate with Cross-Functional Teams

• Work closely with engineering, procurement, and production teams to ensure seamless integration of supplier components into our manufacturing processes while maintaining compliance with quality standards.

Authority:

• Approve or reject supplier quality plans, inspection procedures, and test methods.
• Initiate supplier audits and inspections.
• Issue supplier corrective actions report to suppliers.
• Make recommendations for supplier selection, qualification, and development.
• Represent the company in supplier-related meetings and negotiations.
• Approve or reject supplier-related changes or deviations.