Heather E. Email & Phone Number

Over 20 years of operations leadership and process improvement experience. Hands on, results focused professional known for managing multiple projects, and committed to meeting internal and external customer needs with flexibility, humor and sound judgment. Successfully builds working relationships across an organization through excellent communication and understanding of human and cultural variables.Industry Experience: biotechnology, medical device, life sciences, engineering, electronics, manufacturing, packaging, service delivery, hardware and software development, information technologyAreas of expertise:• Quality Management (CMQ/OE)• Field Service Operations Management• Customer Service Management• Contract Negotiation and Management• Systems Implementation (HR, Audit, CAPA, Document Control, Training Management)• Training Development• Project Management• Process Design• Business Analysis, Metrics and Reporting Systems• Continuous Improvement• ISO 9001 Implementation• Medical Devices • Regulatory Knowledge: FDA/GMP QSR 21 CFR Part 820, Part 11, Part 1040; ISO 13485, MDD• Design Control• SDLC• Change Control• Calibration • Supplier Quality• Document Control• Lead Auditor• Internal, Supplier, and Regulatory Audits• Root Cause Analysis• Corrective Action / Preventive Action (CAPA)• Employee Recruiting, Development and Evaluation

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  California State University-Hayward (East Bay)

  Business Administration With Options In Supply Chain Management And Accounting