Senior Supplier Quality Engineer

Senior Supplier Quality Engineer Must have technical/functional skills: Senior Supplier Quality Engineer will support key projects and activities with critical suppliers in commodities such as injection molding, subassemblies, plastic, and other mechanical and electronic components. These activities may include set up acceptance activities, supplier audits, process validations, quality agreements negotiations, supplier CAPAs as well as supplier change requests (SCR) evaluations and dispositions. Strong hands on experience in supplier qualification, approval, and lifecycle management. Proven capability to create, manage, and maintain approved supplier lists (ASL). Experience conducting supplier quality system audits (on site/remote/desktop). Hands on experience leading or reviewing PPAP submissions for medical device components. Working knowledge of process validation requirements (IQ/OQ/PQ) for supplier processes. Strong understanding of risk based decision making aligned with ISO 14971 principles. Strong skills in root cause analysis and problem solving methodologies. Familiarity with electronic QMS/PLM systems (e.g., TrackWise, Agile, Windchill, SAP). Ability to work effectively with procurement, engineering, manufacturing, QA, and regulatory affairs. Strong supplier communication skills (technical discussions, expectations, escalation). Ability to manage multiple suppliers and PPAPs simultaneously in a regulated environment. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a certified supplier program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur through the supplier CAPA process. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.