Summary
Overview
Work History
Education
Skills
Certification
Timeline
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Angie Arndt

Murrysville

Summary

Results-driven Quality Assurance Specialist with a proven track record at Cook Medical, excelling in regulatory compliance and documentation. Adept at problem-solving and analytical thinking, I enhanced customer satisfaction by swiftly addressing quality issues using automated systems. Committed to maintaining high standards in quality management systems.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Quality Assurance Specialist

Cook Medical
06.2021 - Current
  • -Environmental Monitoring of Controlled Areas by sampling air particulates, viable samples of air and surfaces, and bioburden and endotoxin in the water system
    -Preparing samples for endotoxins and MEAs.
    -Preparing quarterly samples for bioburden and sterilization dose audit.
    -Reviewing and maintaining test results of devices, environmental monitoring, device history records, sterilization records, records stored off site, Internal Investigation Records, CAPA, and External Standards and Records.
    -Opening and closing Adverse Events complaints in Trackwise.
    -Signing off on Device History Records, Test results, and equipment work orders (EAM).
    -Updating controlled procedures and logs in PLM.
    -Reviewing all DHRs to ensure information is correct and parameters were met.
    -Utilizing Access in conjunction with Power Bi to record and trend results.
    -Supplying documentation and information during Audits.
    -Generating Certificates of Analysis and Certificates of Sterilization.
    -Facilitating External Standards and Regulations revisions.
    -Creating metrics for department meetings.
    -Certified in First Aid, CPR, and AED by Heartsaver
    -Trackwise Digital: complaints, non-conformances, and CAPA
    -Updating procedures
    -Reviewing open complaints and sending for closure
    -EDMR for reportable complaints
    -Running article 14 and 15 for business objects
    -Running reports for Digital TrackWise non-conformance’s running weekly meetingsProvided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
  • Ensured product compliance with industry regulations by staying up-to-date on relevant standards and guidelines, implementing necessary changes to maintain conformance.
  • Enhanced customer satisfaction by addressing reported issues promptly and providing effective solutions.
  • Optimized workflow efficiency by introducing automation tools into the QA process where appropriate.

Manufacturing Technician

Philips Medical
10.2019 - 06.2021
  • Trouble shooting and assisting in production of building computers, servers, and switches for Monitoring and Analytics (MA).
    • Using SAP and eDHR Client to generate Quality Notifications for damaged, non-operational, and non-compliant parts.
    • Performing monthly ESD Audits on the production floor.
    • Training new personnel on how to build and run the computers, servers, and switches.
    • Performing monthly ESD Audits on the production floor.
    • Updating engineers, supervisors, and coworkers of the current state of the line.
    • Retrieving information such as serial numbers and builder information from eDHR Reporter.
    • Assisting in requesting, retrieving, and setting out material.
    • First Responder in medical emergencies for the MA floor.

    Certification in Adult First Aid/CPR/AED and Bloodborne Pathogens From American Red Cross.

Education

Biology Nanotechnology

California University of Pennsylvania
California, PA
04-2010

Skills

  • Detail-oriented
  • Quality assurance
  • Problem-solving skills
  • Analytical thinking
  • Team collaboration
  • Documentation and reporting
  • Establishing and enforcing policy
  • Regulatory compliance
  • Data entry
  • Documentation
  • Attention to detail
  • QMS

Certification

Nanotechnology Manufacturing Technology Certification

Timeline

Quality Assurance Specialist

Cook Medical
06.2021 - Current

Manufacturing Technician

Philips Medical
10.2019 - 06.2021

Biology Nanotechnology

California University of Pennsylvania

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