Thomas Wagler
Columbus,OH
Summary
Accomplished Quality Engineer with over seven years of expertise in quality assurance and systems, specializing in laboratory testing, floor inspections, and adherence to Good Manufacturing Practices (GMP). Proven ability to manage water and utility systems while executing validation processes and implementing effective Corrective and Preventive Actions (CAPA). Strong track record of driving continuous improvement initiatives and leading cross-functional teams through complex investigative processes. Expertise in applying principles of sanitary design to uphold optimal safety and quality standards, ensuring compliance and operational excellence.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Senior Quality Engineer
Abbott - Nutrition
06.2025 - Current
- Improved product quality by implementing robust testing procedures and updating manufacturing processes.
- Created detailed reports analyzing trends in product performance, identifying areas for enhancement or improvement.
- Provided technical support in resolving complex quality issues by conducting thorough investigations and presenting data-driven recommendations..
- Implemented effective corrective action plans based on thorough data analysis and investigation findings.
- Contributed to root cause analysis to determine core reason for failures and errors.
- Collaborated with other departments to facilitate successful project completion.
- Collaborated with cross-functional teams to optimize design, manufacturing, and validation processes.
Quality Engineer
Abbott - Nutrition
01.2023 - 06.2025
- Develop and implement quality control processes to improve product quality and reliability.
- Lead cross-functional teams to identify root causes of quality issues and implement corrective actions.
- Conduct statistical analyses and compile data to drive continuous improvement initiatives.
- Collaborate with cross-functional teams to develop and streamline quality management systems.
- Identify and resolve issues found during validation testing.
- Create and implement validation packages on new equipment and facility upgrades.
- Routinely train team members on practices and procedures to maintain quality standards.
- Respond to regulatory inspection observations and address remediation activities.
Document Control Specialist
Catalent (Formerly Bettera Brands)
05.2021 - 12.2022
- Developed and implemented a comprehensive document control system to ensure accurate and efficient management of project documentation.
- Performed regular audits of document control processes and procedures to identify areas for improvement and implement necessary changes.
- Collaborated with various departments to coordinate the review, approval, and distribution of critical documents to ensure timely completion of projects.
- Maintained and updated electronic databases and filing systems to track and organize all project documentation in a secure and accessible manner.
- Provided training and support to team members on document control protocols and systems to ensure compliance with industry standards and regulations.
Quality Systems Specialist
Wannemacher Total Logistics
05.2019 - 04.2021
- Served as back up to the Quality Manager with duties such as batch record review, product testing review, and product label acceptance.
- Maintained documentation system activities through self-created EDMS (Electronic Document Management System).
- Developed and implemented quality assurance processes to ensure compliance with industry standards and regulations.
- Conducted regular audits and inspections to assess the effectiveness of quality control systems.
- Collaborated with cross-functional teams to monitor key performance indicators and drive continuous improvement initiatives.
- Implemented corrective and preventive actions to address third party bench mark inspection observations, internal audits, and weekly management reviews.
Education
Bachelor of Arts - Biology - Chemistry Minor
Bluffton University
Bluffton, Ohio05.2019
Skills
- Managing and responding to FDA audit activities
- Quality & Regulatory Systems Management
- Validation (Part 111, 117, and 11)
- Failure Mode Effect Analysis (FMEA)
- Root Cause Analysis (RCA)
- Proficient in managing multiple responsibilities
- Internal Auditing
- Corrective Action Preventive Action (CAPA)
- Water Systems Analysis
- Local & Federal Health Department Compliance
- Engineering change management
Certification
- Safe Quality Foods Training (SQF) - Alchemy Academy - October 2019
- Hazard Analysis and Critical Control Points (HACCP) - HACCP Consulting Group - January 2019
- Internal Auditing Certification - ISO 19011 - AGET Global Consulting - January 2019
- Preventative Controls Qualified Individual - PCQI - ABI International - July 2022
- Understanding the Process Validation Life Cycle - COBBLESTONE - previously CFPA - February 2022
- Waterworks System Operator - EGLE - State of Michigan - November 2023
Timeline
Senior Quality Engineer
Abbott - Nutrition
06.2025 - Current
Quality Engineer
Abbott - Nutrition
01.2023 - 06.2025
Document Control Specialist
Catalent (Formerly Bettera Brands)
05.2021 - 12.2022
Quality Systems Specialist
Wannemacher Total Logistics
05.2019 - 04.2021
Bachelor of Arts - Biology - Chemistry Minor
Bluffton University
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