Eric Benfey
Quality Assurance Leader | Medical Device & Pharma | CAPA, Complaints, Investigations | Driving Compliance & Operational Excellence
- Role
- Qa Supervisor at Thermo Fisher Scientific
- Location
- Buffalo, NY, US
- LinkedIn followers
- 500 followers
About Eric Benfey
Innovative and process-oriented Quality Leader and Scientist with experience overseeing and managing the implementation of programs, procedures, and projects to ensure quality, compliance, and effectiveness. Excels at leading in-depth investigations, determining level of impact, and devising targeted solutions and corrective actions to mitigate risks. Builds collaborative relationships with cross-functional teams to drive continuous improvement initiatives, resolve problems, and maintain regulatory compliance. Leverages exceptional attention to detail to align projects with customer requirements and manufacturing capabilities, identify process errors, and build more robust quality management systems. Conveys highly technical information to diverse and mixed audiences in an easily understood manner.
Experience
Qa Supervisor
Aug 2025 — Present · Grand Island, NY, US
Lead a team of 4 Quality Engineers supporting GMP-regulated manufacturing operations, overseeingdeviations, CAPAs, change controls, and complaint investigations across product configurations.Improve first-time-right manufacturing performance from 88% to 92% by strengthening deviationmanagement, root cause analysis, and floor-level quality engagement.Achieve >98% on-time closure for deviations and CAPAs within 30-day timelines, ensuringcompliance with cGMP, FDA, and internal quality standards.Execute Lean Six Sigma Black Belt project delivering in cost savings and reducing complaintrates by 70% through SPC, statistical trending, and process optimization.Review and approve 80 CAPAs, 100 change controls, and 50+ complaint investigations annually,ensuring audit-ready documentation and sustained effectiveness.Author 100+ technical reports and customer-facing quality responses supporting 130+ clients,strengthening complaint resolution, regulatory communication, and customer confidence.Serve as QA escalation lead for 20+ high-risk manufacturing events, driving rapid investigation,containment, and product disposition decisions.Maintain cost of poor quality at ~0.28% of revenue by proactively mitigating scrap, deviation recurrence,and manufacturing risk.Leverage Minitab, SPC, and data trending to identify systemic quality issues, including uncovering an85% higher complaint risk tied to large-scale production, driving process improvements.Mentor 10+ cross-functional quality staff, contributing to promotions and site-wide adoption of statisticaland risk-based quality practices.Partner with senior leadership to implement advanced quality planning, control strategies, and continuousimprovement initiatives aligned with global quality standards.Oversee and support regulatory inspections and audits, ensuring audit readiness and compliance with FDA,ISO, and global quality standards across manufacturing and distribution operations.
Education
University at Buffalo
Bachelor of Science - BS, Biological Sciences
2012
University at Buffalo
Master of Science - MS, Biological Sciences
2014
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