Supplier Quality Engineer

Role: Supplier Quality Engineer Location: Gainesville, FL (Onsite) Duration: 12 months Key Responsibilities Ensure supplier compliance with quality system requirements (ISO 13485, CFR 21 Part 820, QSR). Review and process Supplier Initiated Change Requests (DCR, ECR, MCR) and present them for approval. Review supplier documents (MSA, SPC, GD&T, Process Validation, PPAP, FMEA). Conduct supplier pre-assessment and on-site audits. Manage supplier non-conformances, corrective actions, and CAPA closure in Trackwise. Partner with sourcing, RAQA, and manufacturing teams to address quality issues. Maintain KPIs, analyze data, and identify process improvements. Support manufacturing transfers and lead supplier containment actions. Maintain supplier quality records and communication with stakeholders. Drive continuous improvement in supplier quality processes. Qualifications Bachelor's degree in Engineering or Science. 5+ years in quality, engineering, manufacturing, or regulated industries. Strong knowledge of medical device regulations, quality concepts, and risk management. Skilled in audits, CAPA, statistics, and supplier quality management. Excellent communication, project management, and problem-solving skills. Ability to work independently and in cross-functional teams