Heidi Wright Email & Phone Number

-Manage and mentor the Inspection, Document Control, and Quality Engineering teams (approx. 15 employees on average)-Management representative in ISO 13485 certified company, hosting customer and regulatory body audits-Evaluated Quality Management System and implemented updates to support EU MDR compliance and achieved Class Im for measuring devices scope update-Collaborate cross-functionally to promote and implement continuous improvement activities-Perform root cause analysis and implement improvement actions for Corrective Actions raised due to internal trending and audit findings

-Led design transfer projects for Quality preparing PPAP deliverables including PFMEA, gage R&R, capability studies, process flows, and control plans-Reviewed drawings for design for manufacturing / inspection to ensure feasibility while still meeting customer requirements-Created CMM programs to support inspection to GD&T specifications-Investigated and dispositioned manufacturing product and process non-conformances and implemented necessary corrective actions

-Authored, managed and executed IQ/OQ/PQ for process validation on laser welding process including process optimization, writing operation instructions, designing test parts and determining manufacturing process steps.-Documented root cause analysis for complaint investigations and communicated results and corrective actions with the customer-Managed the Supplier Corrective Action Program