Quality System Engineer
CurrentDesigned and documented validation procedures, protocols, and reports for validating equipmentcreated internally and externally. • Served as the Quality Assurance lead on project teams developing new products. • Worked with project teams to release documentation through an electronic quality management system.• Provided direction on process validation for injection molding parameter optimization.• Performed statistical analysis on product dimension and processes, (including capability analysis, ANOVA, Gage R&R).• Developed inspection tools, methodologies, fixtures, and documentation for the inspection of in-house products and purchased products. • Used industry standard software to design labels for use on medical devices, adhering to ISO 152223-1, ISO/IEC 15415-15417, and GS1 standards.• Brought leading customer labeling software online at the company and worked with outside label technicians to realize new printing capabilities.• Worked with customer solutions to create and validate certificates of compliance/acceptance/test.• Designed and executed Factory Acceptance Tests and Site Acceptance Tests in conjunction with suppliers. • Worked within the sustaining engineering team to support ongoing products, including re-validation activities, CAPA support, and Non-conformance corrective actions. • Led risk mitigation and management activities both within a project team and covering functional areas of the company using Risk management plans, reports, and validation master plans.• Met with leadership on a bi-weekly basis to cover ongoing activities and align with tasks. • Served as the quality engineering representative for tracking QE objectives and key results on a weekly basis. • Managed the 3-D printer systems used by all engineering, including both FDM and Stereolithography.
