Bash Quality Systems is the consulting practice of Eric Bash, a quality and
regulatory affairs professional with 15+ years of experience across the medical
device industry and naval nuclear operations.
Eric’s career has been built at the intersection of complex regulated systems: software quality, active device development, human factors, risk management, and AI/ML regulatory strategy. He has held quality engineering and management roles at organizations including Gilero (contract device development and manufacturing), TeraRecon (AI-powered medical imaging SaMD), Teleflex, and ConMed, working on products ranging from infusion pumps and electrosurgical generators to AI imaging systems and drug/device combination products.
Success Stories
- Led the quality buildout for an active device and implantable device program that earned BSI scope extension for design and manufacture
- Led backroom response during an initial FDA inspection, resulting in zero observations
- Built software quality and design quality teams from the ground up, establishing IEC 62304-compliant development lifecycles
- Drove a 63% improvement in CAPA timeliness and an 80% reduction in management review engineering effort through process redesign
- Performed EU MDR Article 120(3) gap analysis for an AI SaMD portfolio
- Extended ISO 14971 risk management to address AI/ML-specific hazards including model drift, training data bias, and output variability
Education and Credentials
MS Systems Engineering
Embry-Riddle Aeronautical University (GPA 4.0, With Distinction)
BS Aerospace Engineering
Embry-Riddle Aeronautical University
INCOSE Certified Systems Engineering Professional (CSEP)
ASQ Certified Medical Device Auditor (CMDA)
ASQ Certified Reliability Engineer (CRE)
ASQ Certified Quality Engineer (CQE)
