Engineer II, Supplier Quality

Quasar Medical; Singapore; Hybrid; SGD 65,000 - 110,000; Full time

Job summary

Quasar Medical is seeking a Supplier Quality Engineer to ensure suppliers meet quality standards, perform audits, drive supplier corrective actions, and support new product transfers in a medical device setting. You will collaborate with cross-functional teams, assess supplier risk, implement improvements, and help maintain regulatory compliance with FDA and ISO 13485 requirements.

The role involves working with suppliers to address quality issues, lead preventive actions, and contribute to

Qualifications

• Degree in Engineering or Science with 2–5 years in quality in medical device/pharma manufacturing.
• Knowledge of regulatory requirements and quality standards including FDA regulations and ISO 13485.
• Excellent English communication and strong analytical/problem-solving skills.
• Experience with supplier quality, audits and CAPA processes.

Responsibilities

• Conduct supplier evaluations based on quality systems and capabilities.
• Lead supplier audits and inspections to verify compliance with standards.
• Drive supplier SCARs, CAPAs and corrective actions in a timely manner.
• Collaborate with cross-functional teams to implement improvements and manage risk.

Skills

Quality assurance

Audit support

Root cause analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Science

Diploma in Engineering or Science

Job description

## Engineer II, Supplier QualityApply: Singapore, Singapore: Full time: Posted Today**Our Culture** We strive for an inclusive company culture, where everyone feels valued, has a voice and is treated fairly, for their personal benefit, the benefit of Quasar, and the benefit of our customers and doctors using our products for patients in need. Job Summary:• 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:• 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• Develop, implement, and maintain supplier quality assurance plans, procedures, and control measures.• Maintaining Approved Vendor / Supplier List.• 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• Prepare and support monthly / annual quality reports to management and other stakeholders.• Ensure proper documentation and traceability throughout the manufacturing process.• 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.Education/Experience and Qualifications:• Degree in Engineering or science, with 2 - 5 years of progressive Quality responsibility, preferably Supplier Quality in medical device / pharmaceutical manufacturing. Diploma holders in Engineering or science with more than 5 years' experience in Supplier Quality, may be considered.• Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.• Good command of English language.• Excellent communication skills• Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.• Able to effectively collaborate with cross-functional teams and present information clearly.Work Environment:• Controlled Environment (Class 10K/100K cleanroom) and office area. Moderate travelling to supplier site will be required.