Ken Petersen
About Ken Petersen
Ken Petersen is a Senior Quality / Validation Engineer at Plexus Corp, where he has worked since 1998. He possesses extensive knowledge of regulatory standards and has successfully implemented process improvements that enhanced manufacturing capabilities.
Work at Plexus
Ken Petersen has been employed at Plexus Corp as a Senior Quality / Validation Engineer since 1998, accumulating 26 years of experience in this role. He is a member of the Task Force for the Global Shop Floor (GSF) MES system, which is being developed in-house. His responsibilities include directing revamp activities and implementing changes to the Data Tracking System to ensure compliance with Part 11 for electronic Device History Recording. Additionally, he assumes the role of QA Manager during the manager's absence and is responsible for training and maintaining Device Tracking and Component Tracking systems at the site level.
Education and Expertise
Ken Petersen studied at Cypress Community College, where he earned an Associate of Science (A.S.) in Engineering. He furthered his education at California State Polytechnic University-Pomona, obtaining a Bachelor of Science (B.S.) in Chemical Engineering. He also studied at Dr C - IBMS. Ken possesses extensive knowledge of 21CFR820 and current Good Manufacturing Practices (cGMP), particularly in the manufacturing of finished medical products.
Achievements in Quality Engineering
Ken Petersen successfully increased process capability from 1.99 to 3.67 sigma on a historically difficult assembly through the Plexus COBRA Six Sigma Manufacturing program. He completed a project for Six Sigma / Design of Experiments (DOE) Green Belt Certification with Honeywell/Allied Signal. His suggestions for improvements have led to achieving a 4.5-5 sigma capability in manufacturing processes. Additionally, he mentors all new Quality Engineers at the site, sharing his expertise and experience.
Role in Compliance and Training
In his role at Plexus, Ken Petersen is responsible for the training and maintenance of Device Tracking and Component Tracking systems at the site level. He supports Corporate IT and manufacturing in these efforts. His involvement in revamping the Data Tracking System has established Part 11 compliance for electronic Device History Recording, highlighting his commitment to quality assurance and regulatory adherence.