Kyla Rodger Email & Phone Number

Detail-oriented, responsible, and hard-working quality engineer with experience in medical device field. Aspires to be a Certified Quality Engineer (CQE) and Six Sigma Black Belt.Technical Skills Include:• Root Cause Analysis• Risk management• Corrective and Preventative Actions• Statistical Tools (Microsoft Excel+ Minitab)• Geometric Dimensioning and Tolerancing (Product Specifications)• Nonconformance investigation and assessment• Product and Process validation planning and support• Data Analysis• Autocad• Microsoft OfficeExperience with:• Working with suppliers in support of supplier quality issues• Working with cross-functional teams on various projects• Ensuring compliance with regulatory agencies (experience with Medical Devices FDA ISO 13485 and ISO 9001 standards)• Quality Systems• Quality plan development• Complaint Handling process• MDR Investigations • Reviewing and contributing to Engineering Study, Installation Qualification, Performance Qualification, and Test Method Validation reportsProjects Include:• Risk Management File remediation for several product lines• Complaints, Nonconformance Investigations, and CAPAs handling for new product under Limited Noncommercial Release• Preparation for internal audit review of specific product lines• Creating and managing tool that tracks all open complaints and action items for Technical Quality Digestive Health Sustaining team• Creating and managing weekly Performance Driven Meetings for Technical Quality Digestive Health Sustaining team

Listed skills include Microsoft Office, Management, Microsoft Excel, Microsoft Word, and 6 others.