Summary
Overview
Work History
Education
Skills
Timeline
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Heui Parsons

Hanover

Summary

Dedicated professional with a strong work ethic and effective communication skills. Proven ability to learn quickly and adapt to new environments. Committed to contributing to team success and achieving organizational objectives.

Overview

12
12
years of professional experience

Work History

QMS Lead

Switchback Medical Center
Brooklyn Park
01.2020 - Current
  • Mentor, train, and lead Document Control, Training, and Receiving Inspection (RI) personnel.
  • Facilitate interdepartmental communication to align Quality Assurance objectives.
  • Coordinate training sessions for new hires on quality assurance processes.
  • Generate new documents and update existing documents based on company needs, regulations, and audit findings to support the Quality Management System.
  • Participate in internal and external quality audits.
  • Provide documentation support for internal and external audits.
  • Maintain compliance with ISO 13485 and 21 CFR Part 820 FDA quality system regulations, related to Document Control, Training, and RI.
  • Support Supplier (ASL) activities as needed, including Supplier Evaluations.
  • Support CAPA activities.
  • Maintain external regulations, standards, and technical library log.
  • Develop and maintain metrics related to Document Control and Receiving Inspection.
  • Support Management Review activities to meet Quality Objectives.

Quality Control Inspector

Teleflex
Plymouth
11.2018 - 12.2020
  • Inspect incoming materials (R&I), and First Article inspection.
  • Verify and approve labels for final packaging.
  • Scan R&I documents for electronic storage.
  • In-process inspection on subassemblies and catheters.

Quality Technician

Sil Pro/Trelleborg
Delano
04.2018 - 09.2018
  • Coordinated FAI activities for equipment and tooling modifications.
  • Submitted ECOs to revise processes, SOPs, travelers, and control of customer drawings.
  • Developed inspection procedures for comprehensive final product evaluations.
  • Supported production teams in analyzing and interpreting customer drawing specifications.
  • Assisted with complaint resolution, containment efforts, and investigations.
  • Participated with MRB to review nonconformances.

Quality Technician

Nordson/Vention Medical
Brooklyn Park
08.2013 - 04.2018
  • Reviewed Device History Records and conducted product audits.
  • Utilized ERP system to execute transactions and research materials effectively.
  • Identified and documented non-conformance issues, supporting investigations and resolutions.
  • Executed disposition tasks according to engineering change orders for products.
  • Assisted during audits and CAPA activities.
  • Trained new employees on R&I processes and cross-trained staff on DHR review.
  • Maintained Device History Records through efficient scanning and filing practices.
  • Provided floor support within clean room environment.

Education

Associate of Arts - General Studies

Iowa Central Community College
Fort Dodge, IA
05-1992

Skills

  • Quality assurance and regulatory compliance
  • Organizational skills, time management, and task prioritization
  • Effective communication, interdepartmental communication
  • Attention to detail
  • Employee training and team leadership
  • Microsoft Office

Timeline

QMS Lead

Switchback Medical Center
01.2020 - Current

Quality Control Inspector

Teleflex
11.2018 - 12.2020

Quality Technician

Sil Pro/Trelleborg
04.2018 - 09.2018

Quality Technician

Nordson/Vention Medical
08.2013 - 04.2018

Associate of Arts - General Studies

Iowa Central Community College

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Heui Parsons