Summary
Overview
Work History
Education
Skills
Timeline
Generic

KATHERYN REYNOLDS

Bloomington,USA

Summary

Bilingual professional (English–Spanish) with extensive experience in medical device manufacturing, quality control, and production assembly. Skilled in SOP compliance, cGMP, and aseptic/cleanroom environments. Strong background in visual, dimensional, and functional inspection, process validation, technical documentation, and continuous improvement (Lean Manufacturing, Six Sigma). Recognized for the ability to train employees, resolve nonconformities, and ensure compliance with ISO 13485, FDA, and international regulatory standards.

Talented Quality Control Inspector driven to improve product quality in manufacturing environments. Provider of relevant and effective product and component tests. Eager to help manufacturers eliminate production errors and increase successful manufacturing figures.

Overview

10
10
years of professional experience

Work History

Quality Control Inspector I

Cook Polymer Technology
Bloomington, USA
01.2024 - Current
  • Perform visual, dimensional, and functional inspections of medical components.
  • Ensure compliance with SOPs, cGMP, and regulatory standards in all inspection and documentation processes.
  • Support quality activities in aseptic/cleanroom environments to ensure product integrity.
  • Report nonconformities and collaborate with Quality Assurance and Manufacturing teams to implement corrective actions and continuous improvement.

Product Builder II

Boston Scientific Corporation
Bloomington, USA
01.2021 - 01.2024
  • Assembled and verified medical devices under cGMP conditions, following SOPs and quality procedures.
  • Operated manufacturing equipment, conducted in-process inspections, and completed batch record documentation.
  • Selected for the Boston Scientific Grow 100 program (2023), focused on operational excellence.

Product Builder I

Boston Scientific Corporation
Bloomington, USA
01.2021 - 12.2021
  • Supported medical device assembly under cGMP and FDA requirements.
  • Followed aseptic techniques and cleanroom procedures to ensure compliance with quality standards.

Cost Engineer

Sipna Consortium
Mexico, Mexico
01.2017 - 12.2017
  • Performed cost analysis and price adjustment calculations for public sector infrastructure projects.
  • Ensured compliance with contractual and government cost requirements.

Instrumentation Analyst

Mexico City Airport
Mexico, Mexico
01.2017 - 12.2017
  • Supported instrumentation and process control systems for airport projects.

Construction Control Analyst

Administrative Services JAVER, S.A. de C.V.
Mexico, Mexico
01.2016 - 12.2016
  • Monitored construction processes, quality compliance, and project control procedures.

Education

Industrial Engineering - Focus in Process Management, Quality Systems, and Human Resources

Santiago Mariño Institute
Venezuela

Skills

  • SOP & cGMP Compliance
  • Aseptic Technique / Cleanroom Procedures
  • ISO 13485 / FDA Regulatory Standards
  • Quality Control & Quality Assurance
  • Lean Manufacturing / Continuous Improvement
  • Visual, Dimensional & Functional Inspection
  • Root Cause Analysis / CAPA
  • Employee Training & Leadership (English–Spanish)
  • Technical Documentation / Batch Records

Timeline

Quality Control Inspector I

Cook Polymer Technology
01.2024 - Current

Product Builder II

Boston Scientific Corporation
01.2021 - 01.2024

Product Builder I

Boston Scientific Corporation
01.2021 - 12.2021

Cost Engineer

Sipna Consortium
01.2017 - 12.2017

Instrumentation Analyst

Mexico City Airport
01.2017 - 12.2017

Construction Control Analyst

Administrative Services JAVER, S.A. de C.V.
01.2016 - 12.2016

Industrial Engineering - Focus in Process Management, Quality Systems, and Human Resources

Santiago Mariño Institute
KATHERYN REYNOLDS