Tiffany Lee

Experience

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  University of the Pacific

  Sept 2013 - May 2015

  - Graded labs of students in general and calculus-based college-level Physics courses.- Troubleshooted computers and instruments used in laboratories.- Provided teaching assistance to professor as needed. - Guided elementary school children to explore the life and responsibilities of adulthood.- Tutored in various subjects after school. - Tutored middle school and high school students in Geometry, Algebra 1 and 2, Biology, and English Literature.- Reported bimonthly progress to parents/guardians on the student's progress.

  • Physics Lab Teaching Assistant

    Aug 2013 - May 2015

  • Community Tutor

    Sept 2013 - May 2014

  • Individual Tutor

    Sept 2013 - May 2014
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  Central Contra Costa Sanitary District

  Jun 2015 - Oct 2015

  Engineering Co-Op

  - Tested nutrients in raw, primary and final effluents. Multiple monthly, weekly, and daily wet chemistry tests on ammonia, organic nitrogen, nitrite, nitrate, UV transmittance, turbidity, total phosphorus, ortho-phosphate, and chemical oxygen demand.- Tested monthly bay samples in Martinez as well as perform extra biweekly tests as asked by engineering department.

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  Accuray

  Nov 2017 - Feb 2020

  Product Surveillance Specialist II

  - Evaluated complaints to identify potential adverse events and determine if MDR is necessary in accordance with 21 CFR 803 and 806, Canadian regulations, European Vigilance Reporting and other worldwide regulatory requirements.- Documented and maintained records of all complaint investigations in accordance with 21 CFR 820 Part 11.- Developed, prepared, and analyzed trend reports from complaint data to support CAPA investigations.- Authored investigations regarding patient safety and product failures.- Owned the Post Market Surveillance team's complaint handling tools, identified process gaps and created processes to streamline complaint processing for the Post Market Surveillance team- Trained incoming Post Market Surveillance team members in complaint handling, and conducted peer review assessments to ensure complaint team's records are processed with an accuracy of 95% or greater. Show less

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  Lucira Health

  May 2020 - Nov 2022

  - Stayed abreast on the latest COVID-19 and influenza scientific literature, competitors, and CDC/ASPR/FDA guidelines to ensure conformance of company’s indications and marketing content.- Technical SME for the Commercial Team and customers.- Developed Sales Training curriculum to monitor team’s understanding and updates on regulatory guidelines regarding COVID-19 and influenza.- Created and iterated curricula and educational content about COVID-19 & influenza diseases and company products for employees, prospect and acquired customers, and the scientific community.- Authored and executed onsite COVID-19 testing workflows and protocols for customer sites.- Proofread Commercial collateral for Sales and Marketing departments to ensure scientific and grammatical accuracy. Show less - Supported sales operations initiatives by working cross-functionally with internal departments, vendors and customers, and successfully launching B2B and B2C programs and onboarding partners, such as the NBA, to ensure the safe return of the public to large events during the COVID-19 pandemic.- Led the collaboration and relationship between multiple cross-functional departments (i.e. Logistics, Sales, Operations, Marketing) and external stakeholders to ensure a smooth, timely delivery and implementation of partnered programs.- Championed projects relating to stability studies and the validation of packaging and shipping configurations by authoring and executing test protocols and reports, as well as interfacing with external vendors to ensure appropriate engagement and accountability in conjunction with internal resources and activities.- Managed cross-functional teams and support development through product development, technology transfer, validation, product manufacturing, commercialization, distribution, storage and transportation, and ensured effective handoff and communication between department functions to execute on important project milestones.- Updated technical and V&V documentation to support the EUA submission that resulted in the first FDA-authorized at-home rapid molecular COVID-19 test in the US.- Managed teams to ensure project deliverables are executed for international markets post-authorization. Show less

  • Product Training & Education Marketing Manager

    Jan 2022 - Nov 2022

  • Customer Implementation Manager

    Sept 2021 - Jan 2022

  • Project Manager

    May 2020 - Aug 2021
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  PROCEPT BioRobotics

  Feb 2023 - now

  - Successfully qualified a third party logistics warehouse location in the United Kingdom within project schedule. This project resulted in an increased presence to support PROCEPT’s second largest and fastest-growing market, minimized turnaround times for sales order fulfillment, obtained an immediate cost savings of $850K+ in a single quarter, and increased the ability to track UK commercial products and marketing units & demos from a single source.- Hold weekly company-wide office hours as the Smartsheet subject matter expert. Developed metrics tools and dashboards to optimize efficiency and KPI tracking across People, R&D, Operations and Warehouse Teams. Show less - Managed the Supplier Change Notification (SCN) portfolio for both the Capital Equipment and the Disables & Accessories business units, ensured open action items were addressed in a timely manner resulting in 0 production line down and 0 customer backorder occurrences, created and owned SCN metrics, and acted as the SCN subject matter expert for cross-functional department meetings.- Successfully implemented a standardized recovery process for failed production parts that can be recovered for new production lots. The project was completed well within schedule and had resulted in recovering components valuing approximately 45% of scrap meanwhile decreasing the risk of production line down occurrences for our high-volume SKUs and implementing an improved method for production lot traceability.- Implemented a standardized in-line rework process that increased production capacity by eliminating the use of NCMRs for known failure modes, decreasing the time of lot production by 60% and increasing unit traceability. This process implementation resulted in the release of commercial products 3 days earlier on average. Show less

  • Senior Project Manager, Operations

    Apr 2024 - now

  • Operations Project Manager

    Feb 2023 - Mar 2024