VINSON M. BALLEK
Buford
Summary
Quality engineering professional with strong background in ensuring product and process excellence. Skilled in root cause analysis, process optimization, and compliance with industry standards. Proven ability to collaborate effectively with teams, adapt to changing needs, and deliver impactful results. Known for reliability, problem-solving skills, and commitment to quality.
Overview
12
12
years of professional experience
Work History
QUALITY ENGINEER
INTUITIVE
06.2024 - Current
- Provided critical support for manufacturing operations by conducting detailed failure analyses, ensuring rigorous documentation standards, qualifying tooling, and implementing robust defect containment measures
- Diligently maintained and periodically updated site-level process FMEAs and risk management files, ensuring continuous alignment with evolving regulatory requirements and operational best practices
- Successfully managed the completion of Corrective and Preventive Actions (CAPAs) and Product Investigation reports (PIRs), significantly enhancing the global corporate labeling process
- Ensured strict adherence to ISI standards and relevant regulations by meticulously overseeing the establishment and implementation of design changes across projects
- Effectively supported the investigation and resolution of non-conformances, coordinating efforts for both internal processes and supplier-related issues to maintain product quality and compliance
- Collaborated in the development and execution of comprehensive process validation and verification test plans, expertly authoring protocols and compiling detailed reports to ensure robust process reliability and product quality
- Successfully replicated, validated, and expanded surgical robotic systems manufacturing and service RMA lines, seamlessly transitioning from an established facility to a new location while ensuring uninterrupted production and quality standards
SENIOR PRODUCT RELEASE SPECIALIST (QUALITY ASSURANCE)
INTUITIVE
07.2021 - 06.2024
- Managed product releases to both internal and external forward stocking locations, ensuring compliance with product specifications and company traceability requirements
- Reviewed DHRs for da Vinci systems and accessories, authorizing the release of products for distribution to customers while ensuring any non-conformances or deviations were properly documented
- Collaborated with internal customers to resolve DHR issues in a timely manner, expediting releases to forward stocking locations
- Provided regular reports on workload status to the team, identifying potential risks to team goals
- Conducted inventory transactions and maintained inventory accuracy for department inventory locations
- Participated in department process improvement projects to mitigate defects and resolve systemic documentation issues
- Supported MDSAP and UL audits to ensure regulatory compliance
- Conducted data analysis to identify root causes of manufacturing non-conformances and implemented process improvements to mitigate future issues
MANUFACTURING ENGINEER (Part Time)
INTUITIVE
05.2022 - 10.2022
- Developed technical documentation, including standard operating procedures, work instructions, and engineering drawings to support manufacturing operations.
- Improved manufacturing efficiency by streamlining production processes and implementing lean methodologies.
- Successfully replicated, validated, and expanded surgical robotic systems manufacturing lines within an established facility
- Verified, documented, and implemented production assembly/test fixtures and equipment
- Ensured adherence to medical device quality system standards, including the resolution of corrective actions, discrepant material dispositions, and ECO implementation
- Provided technical expertise in risk analysis and conducting failure analysis for discrepant production components, assemblies, and field returns
LEAD REMANUFACTURING TECHNICIAN
INTUITIVE
01.2019 - 07.2021
ELECTRICAL MAINTENANCE TECHNICIAN
ARAUCO
04.2018 - 01.2019
SATELLITE COMMUNICATIONS ELECTRONICS MAINTENANCE (2831/2834)
U.S. MARINE CORPS
05.2013 - 05.2018
Education
MBA - Business Administration
Columbia Southern University
Orange Beach, AL12-2021
Bachelor of Science - Cyber Security
Columbia Southern University
Orange Beach, AL12-2020
Bachelor of Science - Electronic Engineering
Vaughn College of Aeronautics And Technology
Flushing, NY12-2012
Skills
- Process validation
- CAPA management
- Failure analysis
- Regulatory compliance
- Data analysis
- Continuous improvement
- Risk management
- Cross-functional collaboration
- Root-cause analysis
Timeline
QUALITY ENGINEER
INTUITIVE
06.2024 - Current
MANUFACTURING ENGINEER (Part Time)
INTUITIVE
05.2022 - 10.2022
SENIOR PRODUCT RELEASE SPECIALIST (QUALITY ASSURANCE)
INTUITIVE
07.2021 - 06.2024
LEAD REMANUFACTURING TECHNICIAN
INTUITIVE
01.2019 - 07.2021
ELECTRICAL MAINTENANCE TECHNICIAN
ARAUCO
04.2018 - 01.2019
SATELLITE COMMUNICATIONS ELECTRONICS MAINTENANCE (2831/2834)
U.S. MARINE CORPS
05.2013 - 05.2018
MBA - Business Administration
Columbia Southern University
Bachelor of Science - Cyber Security
Columbia Southern University
Bachelor of Science - Electronic Engineering
Vaughn College of Aeronautics And Technology
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