Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
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Kaylia Lee

Brooklyn Center

Summary

Accomplished Senior Product Assurance Engineer at HistoSonics with expertise in risk management and continuous improvement. Proven track record in root cause analysis and effective communication, driving quality assurance initiatives that enhance product reliability and compliance. Skilled in improving procedures that streamline processes and elevate standards.

Overview

5
5
years of professional experience

Work History

Senior Product Assurance Engineer

HistoSonics
Plymouth
05.2024 - Current
  • Support ongoing production activities including testing/inspection, DHR review, and NCMR dispositioning
  • Perform investigations on field complaint to determine root cause analysis and review risk management files for updates.
  • Support in Doc Control, IDEF, and Complaint Handling reviews for approval.
  • Perform risk analysis on clinical IDEFs
  • Work with R&D, Software, and Development on new product development activities such as spec reviews, new manufacturing procedures, identify failure modes and risk, and testing/inspection methods
  • Establish return product authorization form and define the SOP
  • Continuous improvement and redline manufacturing procedures, quality documents, and specifications
  • Investigate and provide solutions for CAPA and SCARs utlizing tools such as Fish Bone and 5 Whys.
  • Review and approve equipment file cards, change request, protocols/reports, and validation activities

Quality Engineer II

Nuvaira
Maple Grove
03.2022 - 05.2024
  • Support R&D and manufacturing by providing input and development of material specifications, inspection procedure/method, and manufacturing procedures for NPD and sustainability.
  • Generate and disposition NCMRs.
  • Established the risk management document for the Cooling Cartridges
  • Manage Quality technician on inspection, training, and projects.
  • Implemented RMA disposal process.
  • Generated production scrap spreadsheet for management review metric
  • Provide support for process qualification and validation (IQ/OQ/PQ). Performed IQ for LED Spot Cure equipment. Performed validation activity for Supplier module in GAS.
  • Assist with CAPA investigation and root cause analysis.
  • Participate in continuous improvement activities.
  • Ensure practices follow quality processes and compliance.
  • Approve process change requests through GAS.
  • Redline documents for changes and improvements
  • Participate in IQA and BSI audits. Attend supplier visit and audit for Steris.
  • ISO:13485 Compliant

Supplier Quality Engineer

Abbott
Plymouth
06.2021 - 03.2022
  • Partner and support new product development with core teams in SQE, DA, R&D, PD, and RI.
  • Qualify components with qualification planning and reports following FDA regulations.
  • Maintain relationships with internal and external inspectors/suppliers for new components and qualifications.
  • Visit supplier sites to validate processes and procedures.
  • Host weekly stand-up meetings on inspection progress with Receiving Inspection department.
  • Create technical reports for projects.
  • Validate and create vision system programs and inspection process for RI and R&D to prep for IQ/OQ.
  • Review design specifications and provide input.
  • Participate in continuous process improvements in the overall quality system.
  • Use Windchill and SAP to create and validate new components.
  • Knowledge and use of Minitab to analyze data and statistics. Attended Minitab training course in August 2021.

Senior R&D Technician, Product Development

Abbott
Plymouth
01.2021 - 06.2021
  • Support R&D and engineers with new product development.
  • Design test and inspection method.
  • Exposure to LabVIEW, SolidWorks / CAD.
  • Generate IQ and Change Order in WindChill.
  • Create and redline test method validations for PPQ and DV testing.
  • Participate in the process investigation of non-conformances.

Education

Bachelor of Science - Software Development

Herzing University
Minneapolis, MN
12.2020

Skills

  • Risk management
  • Continuous improvement
  • Inspection procedures
  • Quality assurance
  • Regulatory compliance
  • Root cause analysis
  • Effective communication
  • Team collaboration
  • Problem solving
  • Critical thinking
  • Process development
  • Failure analysis
  • Process improvement

Accomplishments

  • Abbott - Caring Award Recognition for Assisting Supplier Project
  • Abbott - Achieving Award Recognition for G5 RI Test Method Validation
  • Abbott - Enduring Award Recognition for Nanostim (Aveir) Excellence

Timeline

Senior Product Assurance Engineer

HistoSonics
05.2024 - Current

Quality Engineer II

Nuvaira
03.2022 - 05.2024

Supplier Quality Engineer

Abbott
06.2021 - 03.2022

Senior R&D Technician, Product Development

Abbott
01.2021 - 06.2021

Bachelor of Science - Software Development

Herzing University

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Kaylia Lee