DQA Manager
$131,000–$164,000 year
On-site · Irvine, California, United States
Job Summary
Leads, directs and oversees pre-commercialization, design quality assurance efforts for new products and product modifications within ZOLL's R&D; organization, developing system-level testing programs to verify safe operation under bench and simulated clinical use conditions. Defines test strategies and procedures for hardware and software verification/validation, integrates usability and risk management principles, and reports results and metrics to project managers. Oversees a 5-10 person QA team focused on ensuring the quality, safety and performance of defibrillator and patient monitoring products, guiding activities from requirements development through product lifecycle changes. Collaborates with engineering to champion best practices for design quality, and participates in clinical acceptability and verification/validation planning within multiple development projects. Requires a BS degree in Software Engineering or Computer Science (advanced degree preferred), 10+ years in hardware/software design QA, 5+ years in software QA leadership, and familiarity with medical device standards and regulatory considerations.
Required Qualifications
- BS degree in Software Engineering, Computer Science or similar field required
- Advanced degree preferred
- 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
- Familiarity with FDA and International standards and regulations preferred
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