Summary
Overview
Work History
Education
Skills
Interests
Timeline
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Kristina Avery

Kristina Avery

Rochester

Summary

Dynamic and results-driven professional with extensive experience in the medical device industry, specializing in quality parameters, complaint processes, and adverse event reporting. Proven success in leading comprehensive quality audits and implementing robust control measures that enhance product consistency and elevate customer satisfaction. Strategic thinker committed to improving patient outcomes through meticulous attention to detail and dedication to long-term brand integrity. Enthusiastic about contributing expertise to an organization focused on transforming lives through innovative healthcare solutions, leveraging a deep understanding of regulatory standards and industry best practices.

Overview

13
13
years of professional experience

Work History

Quality Control Team Lead

NextPhase Medical
03.2022 - 01.2026
  • Thorough business acumen and strong networking ability with cross functional teams and key stakeholders.
  • Coordinates business schedules for direct reports.
  • Leads and manages a quality team, to ensure that all goals are met in an ethical and efficient way.
  • Cross functional collaboration between various departments to ensure common goals are met or exceeded.
  • Initiates and investigates non conformances on products.
  • Supports executive roles when needed (i.e., vice presidents, presidents, chief executives).
  • Knowledge and understanding of AE reporting, discrepancies, and inefficiencies.
  • Experience with complaint handling, reporting, investigating root cause analysis and non conformance product disposition.
  • Working knowledge of engineer based drawings and schematics with the use of Solidworks.
  • Supports engineering teams with operational process improvements, as well as quality inspection improvements.
  • Prepared reports to dispense information for product teams and compile information supporting long-term company development and success.
  • Reassessed quality control measures at systemic level to proactively identify non-conformances.
  • Established rigorous safety measures for high-stakes and potentially dangerous factory environments.

Quality Technician

NextPhase Medical
10.2014 - 03.2022
  • Timely and efficient preparation of instruments and equipment.
  • Excels working in a fast-paced environment meeting all quality deliverables.
  • Exceptional and accurate data entry skills.
  • Ability to cover assigned tasks during absence of team members or for management as designated.
  • Working knowledge of Global Medical Device including their therapeutic modalities, products, production, lot release, quality parameters etc.
  • Understanding and knowledge of medical device assembly on the shop floor and or inside of a cleanroom environment.
  • Supports documentation control by redlining and revising outdated SOP’s, IP’s, TP’s and work instructions.
  • Submits revised documents utilizing the engineering change notice protocols.
  • Provides support and closure for the CAPA processes (i.e. investigations, root cause analysis, problem identification and collecting information).
  • Sterility review and release of product per ISO 9001 and ISO 13485 standards.

National Guard

United States Army
10.2018 - 03.2019
  • Perform duties and tasks in a timely and efficient manner.
  • Following and executing orders sufficiently.
  • Strategizing solutions within a team setting.

Animal/Kennel Assistant

Country Brook Kennels
02.2015 - 03.2015
  • Assists in organization, planning and scheduling of kennel visitors.
  • Assists in cleaning facility and presents facility in a positive demeanor.
  • Observers and oversees the safety of all animals.
  • Answering a multi phone line and promoting the kennel to the community.

Customer Service Representative

Dunkin Donuts
10.2012 - 08.2014
  • Maintain positive and timely customer service.
  • Accuracy and astute attention to detail in high volume environment.
  • Successfully led and maintained cleanliness, presentation, and workflow throughout the duration of all shifts.

Education

B.S. - Business Administration in Marketing

Southern New Hampshire University
05.2022

Skills

  • Lean manufacturing
  • First-article inspection
  • 5S methodology
  • Key performance indicators
  • Validation testing
  • Quality control checks
  • Waste reduction
  • Continuous quality improvement
  • Quality management systems
  • Customer satisfaction
  • Scrap cost management
  • ISO standards
  • Total quality management

Interests

I enjoy participating in various forms of extracurricular activity that is solely based around fitness, health and mental wellbeing These activities include:


  • High-Intensity Interval Training
  • Team Sports
  • Hiking
  • Kayaking
  • Running
  • Blogging
  • Documenting and sharing travel experiences
  • Road Trips

Timeline

Quality Control Team Lead

NextPhase Medical
03.2022 - 01.2026

National Guard

United States Army
10.2018 - 03.2019

Animal/Kennel Assistant

Country Brook Kennels
02.2015 - 03.2015

Quality Technician

NextPhase Medical
10.2014 - 03.2022

Customer Service Representative

Dunkin Donuts
10.2012 - 08.2014

B.S. - Business Administration in Marketing

Southern New Hampshire University

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Kristina Avery