Zach F.

Experience

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  Zeppe's Italian Ice Franchise LLC

  Mar 2009 - Aug 2010

  Executive Assistant

  I created, edited, and formatted all of Zeppe’s franchise documents and forms. I worked directly with the franchise owner to error proof the Zeppe’s system. Most importantly, I learned first-hand the basics of starting a successful business.

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  Weber State University

  Aug 2010 - Apr 2012

  CRLA Master CeritfiedI helped students with problems ranging from Pre-Algebra to Calculus II. I completed a master tutor project for the Lampros Hall Math HUB. I also graded papers for Introductory Statistics. I answered questions and proofs for the calculus based physics labs. I also helped students plot graphs and use Microsoft excel.

  • Math Tutor

    Aug 2010 - Apr 2012

  • Physics Lab Aid

    Aug 2010 - Apr 2012
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  ATK

  Apr 2012 - Sept 2012

  Computer Science Intern

  Troubleshoot desktop computer problems in a two million square foot facility across multiple buildings. Managed user data and accounts in active directory and completed assigned IT related projects.

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  Fresenius Medical Care

  Mar 2014 - Nov 2017

  QA Statistician

  Sampling Plans: Developed for incoming inspection, product release, process validations, finished material, and reinspection activities.CT Scanner Implementation: Justified and implemented a CT scanner from a company for incoming inspection due to cost benefits.Quality Metrics: Presented for monthly management review meetings and documented management decisions on statistically significant trends.Management Review: Led Management Review and documented decisions on statistically significant trends.FDA Complaints: Managed product complaints for dialyzers and solution products by customer symptom, patient harm, and severity.Quality Metadata: Maintained for 350+ data sources and ensured traceability between quality metrics and supporting metadata.Tableau Analysis: Assisted FMCNA corporate with non-parametric analysis in R and validated statistical applications in the IQ/OQ/PQ format.Bioburden Sampling: Created an IQ/OQ/PQ Matlab application to determine statistically significant bioburden sample sites monthly.OOS Tracking: Developed an Out-of-Specification tracking application in Excel using VBA.Data Acquisition: Designed and implemented InfinityQS software to track defects in Saline and Dextrose IV products with SPC metrics.Quality Analytics: Automated reporting for management review using Python.Sterilization Validations: Assisted with PID controller tuning using Matlab and ensured sufficient F0 values.Electron Beam Sterilization: Calculated dosing requirements for new product development in validation packages for Biological Quality.Onsite Support: Provided six weeks of support at the Concord, CA FMCNA facility to outline QS analytics documentation and address a backlog of Engineering Studies.RPN Calculations: Provided product and in-process annual defect rates for RPN calculations in HAACP tables.Training: Trained staff on the new Quality Monitoring program and Statistics SOPs/WIs. Supported measurement studies for R&D. Show less

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  ICU Medical

  Dec 2017 - May 2019

  R&D Statistician

  ICU Medical is one of the three major IV manufacturers in the United States, alongside Baxter and B. Braun. I joined the team to establish procedures for a new $3 million R&D research lab to develop IV products and further vertically integrate the company. Experimental Design and Validation: Led the design of experiments (DOE) for qualifying new process equipment installations. Bioassay Development: Developed a 21 CFR Compliant U.S. Pharmacopeia based bioassay application for bulk testing of heparin sodium.Statistical Process Control (SPC): Managed SPC for the IV solution filling process and quality testing, ensuring high standards of product consistency.Packaging Studies: Conducted studies comparing Mylar and plastic film enclosures to determine optimal packaging solutions for expiration date and stability testing. Leak Reduction: Designed experiments to reduce channel leaks in IV commodities, improving product reliability and container closure. Supplier Quality Support: Supported statistical tests for supplier quality across all molded commodity products, adjusting preventative maintenance of mold refurbishment. Including cyclohexanone experiments on leechables and extractables.Validation Approval: Approved IQ/OQ/PQ validations for sterilization, stability, and extractables analysis for R&D lots.Bag Tensile Strength and Extrusion: Designed experiments to assess and enhance the tensile strength and extrusion process of IV bags.Visual Inspection Validation: Developed validation protocols for receiving inspections and rework processes.Products:Aminosyn: Conducted HPLC analysis for this amino acid solution used for nutritional support.Heparin Sodium: Developed bioassays and tech transfer applications for this anticoagulant.0.9% Sodium Chloride Injection, USP: Managed SPC and quality testing for this widely used IV solution.Lactated Ringer's Solution: Conducted studies and validations to ensure the quality of this electrolyte solution. Show less

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  MAETRICS

  Dec 2019 - Apr 2020

  Senior Associate - Statistician

  Project Management: Completed seven Statements of Work (SOWs) relating to complaint trending and team performance metrics.Complaint Trending: Developed a complaint trending report for five combination medical device and pharmaceutical products (e.g., EpiPens, injectors, IV products, Thermacare wraps).Adverse Events Analysis: Analyzed adverse events and reporting timeliness, summarizing and trending information from Q3 2019 to Q1 2020.EU MDR Compliance: Ensured compliance with the new EU MDR requirements for trending, including a GAP assessment of quality data reporting articles in the new EU regulation for medical device reporting.Key Achievements:Regulatory Compliance: Successfully produced trending reports in compliance with new EU MDR requirements.Comprehensive Analysis: Provided detailed analysis and summaries of complaint data and adverse events for combination products.GAP Assessment: Conducted a thorough GAP assessment, identifying areas for improvement in quality data reporting. Show less

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  Westgate Resorts

  Nov 2020 - May 2021

  Skier Services Supervisor

  Team Supervision: Supervised a team of 17 ski valet agents across the resort, ensuring efficient operations and high-quality service.Inventory Management: Created an inventory system and tracking in Excel for managing skis, significantly improving organization and control.Operational Efficiency: Managed ski valet operations with a team of 17, effectively covering duties typically requiring 25 to 30 agents.Key Achievements:No Losses: Successfully ensured no skis were lost for the entire season.Recognition: Received excellent reviews for performance and was awarded Employee of the Month for February.Adaptability: Found work during the pandemic, providing a refreshing break from usual engineering roles while excelling in a supervisory capacity. Show less

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  PolarityTE

  May 2021 - Jul 2021

  Quality Engineer Consultant

  PolarityTE holds patents on innovative tissue expansion technologies and autologous regenerative products, these patented methods to develop SkinTE and other groundbreaking therapies that propagate tissue growth several multiples beyond the standard of care skin grafting. QMS Rewrite: Conducted a complete rewrite of the Quality Management System (QMS) for SkinTE, ensuring compliance with Good Manufacturing Practice (GMP) regulations for a combination device-biologic product. Ensured adherence to 21 CFR Parts 11, 211, 600, and 820 regulations throughout the QMS development process.IND Application Support: Performed stability analysis for expiration dating and process yield using Minitab for the Investigational New Drug (IND) application. Tissue Harvest Optimization: Optimized tissue harvest for a surgical stencil, focusing on expansion ratios and dermal contracture.Quality Plan Development: Developed quality plans for all QMS areas, including trend reporting to meet FDA Safety and Innovation Act requirements.Clinical Trial Design: Assisted in analyzing clinical trial results and forming an experiment for Diabetic Foot Ulcers. Clinical Data Analysis: Analyzed clinical trial data for pressure injuries to determine optimal tissue expansion ratios.Document Control: Managed document control for MasterControl and quality approver for batch record reviews.Vendor Qualification: Sourced and qualified contract laboratories to ensure product compliance.Key AchievementsQMS Revamp: Successfully revamped SkinTE's QMS to meet regulatory requirements for combination device-biologic products.IND Support: Played a key role in supporting the IND application, contributing to critical stability and yield analysis.Tissue Harvest Improvement: Enhanced tissue harvest techniques for a surgical stencil and analyzed clinical trial data to advance regenerative medicine products. Show less

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  Utah Regulatory - MPRC Mountain Pacific Regulatory Consulting

  Jul 2021 - Aug 2023

  Quality Engineering Consultant

  Company Assistance: Assisted companies small business medical device start-ups Hoggan Scientific, Xenocor, and B&D Dental Corp. in developing and implementing robust quality systems to ensure compliance with industry standards and regulatory guidelines.Regulatory Support: Provided comprehensive Quality Management Systems (QMS) support to start-ups, specializing in 21 CFR 211, 21 CFR 820, and ISO 13485 regulatory requirements.Role Transition: Successfully transitioned to a permanent consulting role at B&D Dental, leveraging extensive QMS expertise to enhance operational efficiency and regulatory compliance.Key Achievements:Regulatory Assistance: Delivered tailored regulatory assistance, enabling start-ups to meet stringent quality and compliance standards with a successful FDA audit.System Development: Facilitated the development of compliant and efficient quality management systems, contributing to the growth and success of emerging companies. Show less

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  Snowbird

  Nov 2021 - now

  Revenue Analyst

  Lodging Pricing: Managed all lodging pricing strategies for Snowbird's four properties, including one time-share property.Revenue Reporting: Oversaw week-over-week (WoW) and year-over-year (YoY) revenue reporting, providing accurate and timely analysis of financial performance.SMSHost Reporting: Conducted SMSHost reporting, including updating rates on extranets to ensure all platforms reflect current pricing and availability.Lodging Demand Analysis: Developed and managed lodging demand analysis to determine optimal areas for group placement, enhancing occupancy and revenue.Market Segment Management: Managed pricing and availability for various market segments, including transient, group, and owner, to maximize revenue across all customer categories.Automated Reporting: Implemented automated reporting and rate uploading, improving efficiency and accuracy in revenue management processes.Key Achievements:Demand-Based Pricing: Successfully developed and implemented demand-based pricing strategies that significantly improved revenue and occupancy rates over the market competition.Revenue Reporting Efficiency: Enhanced the accuracy and efficiency of revenue reporting through automated processes.Group Placement Optimization: Optimized group placement strategies, leading to better utilization of lodging facilities and increased group bookings. Show less

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  B&D DENTAL CORP

  Feb 2023 - now

  Quality Management Consultant

  Reporting to a Quality and Regulatory Affairs Director Consultant, the QMS is managed extensively by a two-person consulting unit via change control in direct collaboration with the General Manager, Production Manager, COO and CEO.B&D Dental Technologies hold patents on proprietary methods that significantly enhance the quality of their zirconia products, which include high-translucent and high-strength materials. These methods involve reducing zirconia particles to nano sizes and using a colloidal processing technique, resulting in homogeneous structures with superior mechanical and aesthetic properties than any dental product currently on the market. Largely the sole company internationally developing zirconia using this novel manufacturing technique, where I have authored 90% of the process documentation, forms, maintenance procedures, and work order execution system. Process Documentation: Created, maintained, and updated all process documentation for B&D Dental Corp., ensuring accuracy, compliance, and alignment with company standards and regulatory requirements imposed by FDA audit findings. Regulatory Compliance: Managed all FDA-related tasks in compliance with 21 CFR 820 regulations, excluding external communications with the FDA, complaints, and supplier approval.Quality Management Systems: Implemented, monitored, and continuously improved the company’s quality management systems to meet the highest standards of quality and regulatory compliance.Internal Reporting: Prepared and managed monthly internal reports, ensuring timely and accurate documentation of quality management activities and compliance status.Work Order Development: Designed a work order system that generates over 200 manufacturing work orders for generic product and over 1500 private labels. Training: Conducted training sessions for staff on quality management processes and regulatory compliance requirements, fostering a culture of quality and continuous improvement. Show less