Summary
Overview
Work History
Education
Skills
Early Career
Volunteer Experience
Certification
Timeline
Generic

Chandra N. Mironas

Swansboro,NC

Summary

Proactive professional with a strong ability to adapt to new challenges. Demonstrated problem-solving skills and a history of building effective relationships with clients and colleagues. Committed to driving team success and delivering positive outcomes.

Overview

8
8
years of professional experience
1
1
Certification

Work History

Quality Engineer

LivaNova
Arvada, CO
03.2021 - 03.2025
  • Led investigations of nonconforming products, initiating stop shipments and field actions based on risk assessments.
  • Managed CAPA projects through trend analysis and cross-functional collaboration for sustainable improvements.
  • Conducted ISO 13485 internal audits while supporting supplier quality management initiatives.
  • Collaborated with vendors to address issues and validate corrective and preventive actions.
  • Maintained risk management files and quality control plans, assessing impacts of change controls.
  • Delivered key performance indicators (KPIs) while ensuring compliance with complaint handling and MDR reporting.
  • Coached and mentored team members to enhance overall performance and skill development.
  • Supported implementation of new barcoding software in production environments to increase efficiency.

Production Supervisor

LivaNova
Arvada, CO
02.2019 - 03.2021
  • Coordinated production requirements with material handling and staffing functions to enhance efficiency.
  • Maintained accurate records of employee attendance and working hours for billable cycle calculations.
  • Developed innovative operational processes to maintain competitiveness in the market.
  • Monitored staff training and output to achieve compliance, productivity, and revenue targets.
  • Mentored and coached over 40 non-exempt team members to improve performance.

Production Supervisor

Septodont
Louisville, CO
01.2018 - 10.2018
  • Managed front-line manufacturing operations while enforcing GMP practices.
  • Executed performance reviews and developed plans to enhance productivity.
  • Led investigations of deviations (DIRs, MDIs) and processed documentation changes.

Supervisor, Operations

Upsher-Smith Laboratories
Denver, CO
11.2016 - 01.2018
  • Directed packaging and manufacturing operations to ensure GMP compliance.
  • Conducted root cause investigations and implemented corrective actions.
  • Championed continuous improvement initiatives to enhance operational efficiency.
  • Served on Safety Committee, advocating for workplace safety practices.

Education

Master of Science - Project Management

Colorado State University – Global
05.2020

Bachelor of Science - Chemical & Biological Engineering, Chemistry, Spanish

Colorado State University (CSU)
05.2011

Skills

  • CAPA and nonconformance investigations
  • Root cause analysis
  • ISO 13485 and FDA compliance
  • Quality audits
  • Risk management and complaint handling
  • Process validation and change control
  • SOP development
  • Cross-functional leadership

Early Career

  • Assistant Brewer, Southern Barrel Brewing Co.
  • Senior Production Operator, Pacira Pharmaceuticals
  • Engineering Intern, USDA Forest Service

Volunteer Experience

Cherry Point Spouse Club, Military Spouse Active Member, 01/2025 - Present

Evaluate and allocate grant funding to nonprofit organizations

Collaborate with committee members to ensure equitable fund distribution

Certification

Lead Auditor: ISO 13485:2016 with FDA 21 CFR 820

Six Sigma White Belt

Timeline

Quality Engineer

LivaNova
03.2021 - 03.2025

Production Supervisor

LivaNova
02.2019 - 03.2021

Production Supervisor

Septodont
01.2018 - 10.2018

Supervisor, Operations

Upsher-Smith Laboratories
11.2016 - 01.2018

Master of Science - Project Management

Colorado State University – Global

Bachelor of Science - Chemical & Biological Engineering, Chemistry, Spanish

Colorado State University (CSU)

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Chandra N. Mironas