Sr. Supplier Quality Engineer/Supplier Quality Engineer

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 the 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 projects. Documentation and Reporting Prepare and support monthly / annual quality reports to management and other stakeholders. Ensure proper documentation and traceability throughout the manufacturing process. Collaboration 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 reports 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 of 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. #J-18808-Ljbffr