Required Education: Bachelor's degree in engineering Required Experience/Skills: Minimum 3+ years of Quality Engineering experience Experience in process control, process improvement, testing, and inspection activities Experience managing Non-Conformances (NC) and Corrective and Preventive Actions (CAPA) Experience with electronic quality management systems such as TrackWise Strong root cause analysis and problem-solving skills Experience investigating and dispositioning non-conforming products within MRB Experience supporting manufacturing complaint investigations and product field actions Knowledge of supplier quality management and Supplier Corrective Action Requests (SCAR) Experience managing Supplier Initiated Change Requests (SICRs) Experience with Production Part Approval Process (PPAP) Knowledge of process validation, equipment qualification, and Measurement System Analysis (MSA) Ability to analyze quality data, identify trends, and implement corrective actions Strong cross-functional collaboration and communication skills Ability to work independently with minimal supervision Strong attention to detail and analytical skillsPreferred Experience/Skills: Medical device or regulated manufacturing industry experience Experience supporting manufacturing transfers between plants/facilities Experience with supplier part certification programs Experience developing and improving manufacturing and distribution processes Experience creating, reviewing, and modifying quality procedures Experience in monitoring quality KPIs and performance metricsSenior Quality Assurance Engineer Responsibilities: Work closely with Operations and business functions to ensure product and process quality performance Collaborate with internal teams and suppliers to resolve quality issues and non-conformances Own and manage NC and CAPA records through timely closure in TrackWise Support manufacturing-related complaint investigations and product field actions Investigate and disposition non-conforming products through the MRB process Communicate with suppliers regarding quality issues and initiate SCARs when required Manage Supplier Initiated Change Requests (SICRs) and coordinate cross-functional reviews Support manufacturing transfers and associated quality activities Identify and execute supplier quality improvement and part certification opportunities Improve internal manufacturing and distribution processes for existing products Assess and approve internal and supplier-driven change management activities, including PPAP submissions Participate in the creation, review, and revision of quality procedures Support process validation, equipment qualification, and MSA activities Monitor quality KPIs, analyze trends, and implement corrective actions as necessary Perform other related duties as assigned **Only those lawfully authorized to work in the designated country associated with the position will be considered.** Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify).