Cara Beougher
Associate Vice President, Global Quality Assurance @Bio-Rad Laboratories
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WORK HISTORY
Associate Vice President, Global Quality Assurance @Bio-Rad Laboratories
Hercules, CA, US
Lead global quality strategy and execution for 15+ manufacturing sites and 20+ distribution locations worldwide (U.S, Europe, LATAM, APAC, and South Africa), ensuring full alignment with FDA, ISO 13485, ISO 14971, EU MDR, IVDR, and MDSAP requirements. •Spearheaded global QMS transformation, standardizing key quality processes and implementing an enterprise-wide electronic QMS, reducing certificates by 20% in 18 months.•Directed global inspection readiness, achieving zero critical findings in FDA, EU, and MDSAP inspections. •Rolled out digital quality dashboards to track and report KPIs (complaints, field actions, supplier nonconformances), strengthening executive visibility and proactive issue management. •Realigned 150+ product managers from Marketing to QARA, elevating complaint handling and post-market surveillance capabilities.
EDUCATION
University of Arizona
Bachelor of Science, Health Sciences/Physiological Sciences
University of Arizona
Bachelor of Science - BS, Health Science
Palmer College of Chiropractic San Jose, Calif.
Doctor, Chiropractic
ABOUT CARA BEOUGHER
Strategic and transformational global quality leader with 20+ years of experience advancing operational excellence, regulatory compliance, and digital transformation across the medical device and diagnostics industry.Proven success in leading large global quality organizations (~200 professionals), harmonizing multi-site Quality Management Systems, and delivering measurable improvements in compliance, efficiency, and quality culture. Recognized for expertise in FDA, EU IVDR, ISO 13485, and MDSAP requirements—and for building inspection-ready systems and teams that enable business growth and regulatory confidence.Core strengths include:*Driving enterprise-wide quality strategies aligned with FDA, ISO 13485, IVDR, and MDR requirements*Building and optimizing QMS across complex, matrixed organizations*Leading regional quality teams while partnering with global RA/QA functions to harmonize operations*Overseeing complaints, CAPA, adverse event reporting, and service quality functions*Supporting business development and new product launches with quality leadership from concept to commercializationI am passionate about shaping a strong quality culture, developing high-performing teams, and driving continuous improvement—ensuring reliable product supply and meaningful health outcomes worldwide
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