Teams at JenaValve Technology

Supports quality systems and compliance activities across regulated medical device or life sciences operations. Responsibilities include internal and external audits, CAPA and nonconformance management, quality metrics, inspection readiness, management review, standards evaluation, root cause investigations, and continuous improvement. The role partners with Regulatory, Manufacturing, and R&D teams on eQMS enhancements, validation, risk management, FDA and Notified Body inspections, and global quality KPI harmonization.

Leads quality systems and quality engineering activities for medical device product development and commercialization. Manages CAPA, nonconformance, change control, audits, management reviews, quality metrics, inspection readiness, eQMS enhancements, software validation, returned goods compliance, and QMS improvement initiatives. Collaborates with Regulatory, Manufacturing, and R&D teams, supports global KPI harmonization, and provides technical guidance to quality specialists and junior engineers.

Develops and documents components and subsystems for transcatheter heart valves and delivery systems. Performs engineering analysis, feasibility testing, risk analysis, and design verification. Collaborates with Quality and Manufacturing on procedures, processes, and product transfer to external manufacturers. Procures components, develops assembly procedures, and supervises technicians while ensuring compliance with medical device quality systems.