ZOLL is seeking a DQA Manager for its Irvine, CA location, who will lead quality assurance efforts for new and modified medical products. The role emphasizes system-level testing and collaboration with cross-functional teams to ensure product safety and efficacy in alignment with regulatory standards
Job Summary
Leads, directs and oversees pre-commercialization, design quality assurance efforts related to new products and product modifications within ZOLL's Research and Development organization.
Responsible for developing and executing system level testing programs to verify that each new and/or modified product is safe and operates as intended under both bench testing and simulated clinical use conditions.
Focusing primarily (but not exclusively) on software quality and performance, directs the efforts of 5-10 subordinates charged with verifying the quality, safety and expected performance of ZOLL's defibrillator and patient monitoring products.
Matching Summary
Match Score: 85
ZOLL is seeking a DQA Manager for its Irvine, CA location, who will lead quality assurance efforts for new and modified medical products. The role emphasizes system-level testing and collaboration with cross-functional teams to ensure product safety and efficacy in alignment with regulatory standards.
Skills & Requirements
Must-have
System level testing programs
Software quality and performance
Risk management and usability principles
Design verification and validation procedures
Hardware and software quality assurance
Nice-to-have
Clinical environments and issues
Business acumen
Entrepreneurial spirit
Key Requirements
BS degree in Software Engineering, Computer Science or similar field required
10+ years experience in hardware and software design quality assurance required
5+ years' hands on experience in software quality assurance associated with real-time embedded software systems required
5+ years' experience in a software design quality assurance leadership position required