Isaac Thon
Apple Valley
Summary
Quality assurance professional with proven track record of enhancing product reliability and streamlining processes. Known for strong focus on team collaboration and achieving consistent results while adapting to evolving project demands.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Quality Technician
Primordial Soup
St. Paul
08.2017 - Current
- Responsible for creating the documentation and the execution of inspections, including FAI, sample data inspection, and final inspection.
- Responsible for accurate and timely data collection, documentation, and analysis to support quality activities.
- Working with manufacturing team to ensure best methods of inspection are followed.
- Responsible for drafting, assembling, and filing of Certification packs and Device History Records.
- Responsible for the timely execution and documentation of Primordial Soup internal assembly processes and outside services.
- Responsible of shipping and receiving. Including creating purchase orders, labeling, and controlling of inventory.
- Ensure materials are traceable through labeling, and material certification recording.
- Serve as a Project Team Member assisting with project team meetings, design reviews, and supporting documentation.
- Led root cause investigations using NPAR and CAPA methodologies to identify nonconformances, implement corrective actions, and prevent recurrence of quality issues.
- Experienced working within ISO 13485 and ISO 9001 regulated environments to ensure quality system compliance.
- Created and managed DCOs and PCOs to support process improvements.
- Maintained calibration schedules and ensured accuracy of precision measurement equipment.
Shop Hand
KEB America, Inc.
Shakopee, MN
01.2016 - 08.2017
- Meticulously assembled and fitted parts for subassemblies and final products. Demonstrated precision in operating and maintaining machinery for optimal performance.
- Proposed and implemented process improvements in riveting and precision grinding techniques, leading to measurable enhancements in product quality.
- Picking and cleaning of various materials, parts, and hardware.
Yard Operator
Safety Signs
Lakeville, MN
08.2013 - 01.2016
- Certified Traffic Control Flagging.
- Managed equipment inventory, ensuring timely jobsite supply.
- Operated heavy machinery, including Bobcat and Internationals.
- Maintained yard organization and cleanliness.
Education
High school Diploma -
Prior Lake
01-2015
Skills
- Proficient in SolidWorks Inspection
- Calypso software knowledge
- Experience with EZ Cad 2
- Proficient in Microsoft Office
- Basic understanding of various measuring equipment
- CMM measurement skills
- Hands-on assembly skills
- Customer interaction
- Audit assistance
- Process mapping
Certification
- ISO 13485 Lead Auditor
- ISO 13485 Overview training for Medical Devices & IVD Manufacturers
- QMS Training for Medical Devices: ISO 13485:2016 and FDA QMSR
Timeline
Quality Technician
Primordial Soup
08.2017 - Current
Shop Hand
KEB America, Inc.
01.2016 - 08.2017
Yard Operator
Safety Signs
08.2013 - 01.2016
High school Diploma -
Prior Lake