Sofie Middleton Email and Phone Number

Managed Oyster Creek Collection orders, deliveries, and trade program as a one-person team including but not limited to working with designers to create custom orders, order processing, communicating with two manufacturers, customer service (online, in-store, by phone), planning and logistics for all deliveries across the USA with freight provider, coordination with customers leading up to and on delivery day, and problem resolution regarding damagesEstablished work order and order tracking system with two manufacturers for efficiency and organization across product linesPlanned all aspects of Oyster Creek Collection upholstery line launch and other new product development within case good line including design, prototype creation, photography, marketing, website development, and fabric swatch library creationOperated showroom floor by receiving product, managing inventory in-store and online, acting as the sole retail associate, and conducting and fulfilling online ordersCreated and maintained point of sale system for Oyster Creek Collection through ShopifyPlanned and executed all showroom events by coordinating vendors, refreshments, decorations, and publicityServed as main point of contact and IT for website development and maintenance

Led overhaul of Trilliant Surgical's process for FDA Medical Device Reports (MDRs) per 21 CFR 803, including assessment, generation, and submission; company-wide MDR SMEFunctioned as Regulatory Affairs approval representative throughout product launch of Arsenal Plating SystemCompiled, analyzed, and reported performance of medical device trends as part of annual Post-Market Surveillance in compliance with national and international regulations, 21 CFR 820 and ISO 13485:2016Supported launch of MasterControl as Regulatory Affairs representative and Validations SMEAudited 11 of 15 Trilliant quality systems over a 4-month period through Internal Audits to ensure compliance of systems and processes with external regulationsCurrently perform and organize quarterly standard and regulation review and update initiativeCurrently support external regulatory audits, including FDA and ISO, during pre-audit, mid-audit, and post-audit activitiesCurrently manage Internal Audit investigation, corrective action, and effectiveness check system to ensure timeliness and compliance

Acted as project manager for Trilliant Surgical performance qualification (PQ) program overhaul as top-priority improvement initiativeEnhanced procedural guidance for Validations program within SOPs and controlled forms and created a new standardized format for qualification protocols and reports, streamlining the writing process and template for consistency, efficiency, and accuracyOrganized an objective system for grouping all product lines into categories for PQ execution and created feature-based risk approach to protocol acceptance criteriaExecuted over 30 qualifications spanning a six month period to bring all Trilliant Surgical implants into compliance for qualification requirementsReceived compliments from national expert for PQ efforts Acted as project manager of qualification efforts, for both vendor and internal processes, for two product launchesOrganized a system to qualify all vendor-supplied product on an as-received basis Assisted in transitioning implants to sampling plans based on successful PQ completion Assisted in Quality Department functions such as Device History Record review, Quality Plan management, Medical Device Reportability assessments, and Inspection Report standardization

Provided product demonstrations of hardware and software to prospective customers and effectively communicated benefits of Hexagon’s products for complex metrology applicationsDeveloped, prepared, and conducted training classes to customers in machine operations andprogramming (usually in groups of 5-12 people) while fostering participation and relationships with customers through effective interactionProvided technical support to our customers both onsite and by phone

Previously Hospira, a Pfizer company. This position is a permanent role and an extension of the previous rotational program position.Conducted Annual Product Quality Review to verify consistency of site manufacturing processes in drug productsWorked toward the development of a Compendial Compliance Process for Austin site to replace Pfizer corporate model and initiate good monitoring practices for ICU Medical Infusion Systems with regards to regulatory complianceCreated Design of Experiments for Engineering Study to address regulatory commitments and restore compliance to laboratory processes through statistics, engineering, and cross-functional teamwork

Quality Program Management and Manufacturing SupportCompleted capital project to install process aids on Sterilization floor through documentation activities, project management, training, and validationsUtilized statistics skills, Minitab, and InfinityQS to analyze and confirm safety of expiry standardsParticipated in transition efforts to align site practices with Pfizer quality standards through site wide communication and compliance with corporate-mandated timelinesActed as part of audit support staff in both internal, corporate audits and external auditsEnvironmental Health and SafetyLed combustible dust evaluation project by communicating with testing labs, arranging dust collection, and relaying test results to site and corporate officesImplemented successful site wide cutting tool replacement project while learning skills in project management, communication, presentation, and internal technology systemsParticipated in radio frequency and noise monitoring and mapping as preventative maintenance and employee safety initiatives

Assisted graduate student in development and testing of novel catheter to improve delivery of chemotherapeutics to brain tumorsDesigned, 3D-printed, and tested fixture used to assemble catheter with precision and ease, at a level of high repeatability

Assist product development staff in all aspects of design control activities, to include: Design History File documentation, Customer Requirement/Design Input Requirement generation, Risk Analysis/FMEA, Verification and Validation planning and execution, product design, packaging design, cleaning/sterilization planning, Design for Manufacturability, etc.Participate in Document Control activities, such as Engineering Change Order documentation and tracking Design History Record management.Assist Quality Assurance staff in drafting SOPs, Work Instructions, Inspection Procedures, and other Quality System documentation.

Work with a staff facilitator to plan a weekly seminar, interact with students outside of seminar time on a one-on-one basis, and assist first-year students in making the transition from high school to college life

Supervise operators, calibrate daily schedules, and monitor day-to-day operations while acting as floor manager of Potato Chip department once a week. Streamlined seasoning equipment to provide for more consistent set-up following changeovers and sanitation and restructured slicer head rebuild program to ensure all equipment was accounted for and updated as summer intern projects.

Work with middle school and high school aged youth to confidently integrate STEM content and 21st century skills into informal and formal learning environments through hands-on, design-based learning