Kathy Bales
About Kathy Bales
Kathy Bales is a Staff Quality Engineer with a diverse background in quality assurance and regulatory affairs, particularly in the medical and pharmaceutical sectors. She has held various positions across multiple companies, demonstrating expertise in compliance and leadership skills.
Work at Plexus
Kathy Bales currently serves as a Staff Quality Engineer at Plexus Corp. since 2020. Her role is based in Livingston, Scotland, United Kingdom. Prior to her current position, she worked at Plexus Corp. from 2018 to 2020 in Louisville, Colorado, where she also held the position of Staff Quality Engineer. Her responsibilities include ensuring compliance with quality management systems and regulatory affairs, particularly in the medical device sector.
Education and Expertise
Kathy Bales has a diverse educational background. She studied Nursing at the University of Florida and Lake-Sumter State College, where she achieved an Associate of Science degree. She also holds a Bachelor's Degree in Communication, Journalism, PR & Marketing from the University of Central Florida. Additionally, she completed leadership and management training at FranklinCovey, focusing on skills such as time management and leadership. Her education equips her with a unique combination of skills in communication and quality assurance.
Background
Kathy Bales has extensive experience in quality assurance and regulatory affairs, particularly within the medical and pharmaceutical industries. Her career spans several roles, including Senior Quality Assurance Engineer at Vention Medical and Compliance Specialist at Encision. She also served as Director of Quality Assurance at Flashback Technologies. Her background includes significant experience in creating and improving Design Control procedures, with a focus on FDA 21 CFR 820 compliance.
Previous Work Experience
Before her current role at Plexus, Kathy Bales held various positions in quality assurance and management. She worked as a General Manager at American Multi Cinema of Florida Inc for 11 years and as a QA Associate & Document Control Coordinator at Great Basin Scientific for 2 months. Additionally, she was a Quality Assurance Document Control Supervisor and Technical Writer at Agilent Technologies. Her diverse work history contributes to her expertise in quality management systems.
Achievements in Quality Management
Kathy Bales demonstrates a strong background in quality management systems, crucial for ensuring compliance in the medical device and pharmaceutical sectors. Her experience includes extensive leadership training and a focus on regulatory affairs. She has developed and improved Design Control procedures, enhancing compliance with industry standards. Her unique combination of skills in communication and nursing further supports her effectiveness in managing quality assurance.