Supplier Quality Lead Medical

Experience: 8-10 years Key Responsibilities: Lead supplier quality engineering activities for medical mechanical components and assemblies. Evaluate and qualify new suppliers based on quality, capability, and compliance requirements. Conduct periodic supplier audits focused on regulatory and medical device quality standards. Manage supplier-related nonconformances, root cause analysis, and corrective/preventive actions. Drive continuous improvement programs across the supplier network to reduce defects and increase process capability. Collaborate with internal cross-functional teams including design, manufacturing, and regulatory. Review and approve PPAP, FAI, and other supplier documentation. Ensure supplier adherence to ISO 13485, FDA requirements, and other applicable medical standards. Monitor supplier performance metrics and develop improvement roadmaps. Provide technical leadership and mentorship to junior SQE members. Mandatory Skills: Strong experience in supplier quality engineering within the medical or healthcare device domain. Knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820, and other medical regulatory standards. Hands-on expertise in PPAP, FAI, RCA, CAPA, and audit processes. Mechanical engineering background with understanding of medical components and manufacturing processes. Experience in working with global suppliers and cross-functional teams. Excellent communication, analytical, and problem-solving skills. Preferred Skills: Lean Six Sigma certification (Green Belt or higher). Experience with risk management tools such as FMEA. Knowledge of advanced measurement systems and metrology tools. Experience in automation or digital quality tools. Project management skills.