Supplier Quality Engineer

Essential Duties and Responsibilities: Include the following. Other duties may be assigned. • Supplier Management: - 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. - 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. • Process Improvement: - 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. 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.