Oversaw quality management systems including CAPA process, internal audit process, and management review (self plus one exempt, direct report). Served as alternate management representative and CAPA Review Board member. Managed document control department – engineering change process, document libraries, standards management (self plus three non-exempt, direct reports). Served as SME for production process validation projects, as well as site representative for multi-site teams including non-product software validation, document management, engineering changes, and good documentation practices. Served as master trainer for quality system procedures. Owned multiple, concurrent CAPA projects and internal audit responses.

Served as quality engineer for video endoscope and subassembly production departments, as well as Subject Matter Expert for process validation. Provided QE support for document control department, as well as backroom support for external audits and inspections. Served as quality engineering reviewer of test protocols and engineering changes, and as master trainer for quality management system procedures and new hire training for quality. Utilized Lean principles to improve throughput and quality of subassembly production cells. Implemented tools such as Standard In-Process Storage (SIPS), defect reduction using A3 thinking, cell re-organization, and production tracking. Applied skills from Toyota TSSC and Weaver Consulting problem-solving training to production issues. Led creation of master validation plans, master control plans, and FMEA documents.

Supported quality engineering remediation for various clients, as well as development and use of quality system software tools developed by company. Provided compliance remediation and manufacturing quality transformation in major orthopedic device company. Reviewed, coached and approved process validation activities including measurement system analysis, sampling plans, method validations, and all validation phases (EQ/IQ/OQ/PQ/PPQ). Created new master validation plan SOP and new, risk-based attribute and variable test method validation SOP. Developed validated spreadsheet that automates planning and reporting for attribute test method validations.