DQA Manager

ZOLL Medical Corporation • Irvine, CA

34d

About The Position

At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service. At ZOLL, you won’t just have a job. You'll have a career—and a purpose. Join our team. It’s a great time to be a part of ZOLL! 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. Develops testing programs based upon product requirements, applicable safety/performance standards, risk management and usability principles as well as documented and implied user needs/requirements. Reports testing results to Project and R&D managers while computing quality metrics and tracking progress on unresolved issues. 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. Design quality assurance eff01ts are lifecycle-oriented beginning during product requirements development phase and continuing throughout the product's life time. Works directly with Project Managers, Engineering Managers and design teams to champion best practices that lead to higher design quality and to ensure that verification and validation efforts are efficiently and effectively

Requirements

• BS degree in Software Engineering, Computer Science or similar field required and Advanced degree preferred
• 10+ years experience in hardware and software design quality assurance required and 5+ years' hands on experience in software quality assurance associated with real-time embedded software systems.
• required and 5+ years' experience in a software design quality assurance leadership position required
• Thorough understanding of software quality assurance principles, practices and metrics as well as software development and testing best practices that taster high quality software.
• Hands on experience using modem software development and quality assurance tools.
• Excellent written, verbal and interpersonal skills.
• Business acumen

Nice To Haves

• Familiarity with FDA and International standards and regulations applicable to medical device hardware and software development, verification and validation preferred.
• Understanding of clinical environments and issues related to the clinical application of medical electronic products desirable.

Responsibilities

• Plans, budgets, schedules and tracks the efforts of Design Quality Assurance teams responsible for developing and executing system level design verification and validation procedures associated with multiple simultaneously running development projects.
• Establishes policies and procedures related to the planning and cooperative execution of hardware and software quality assurance efforts by development and quality assurance teams.
• Works with individual development teams to define, plan and integrate Design Quality Assurance efforts into each new product development project.
• Leads and manages the development and execution of system level hardware and software verification and validation procedures for new and modified products that integrates simulated use, clinical performance, standards, risk management and usability principles into the testing process.
• Reviews, audits and approves all design quality assurance procedures, testing results and documentation associated with the release of new products and product design changes.
• Responsible for the development, documentation, maintenance and execution of standardized system level validation procedures for new ZOLL products.
• Develops test strategies, procedures and test setups needed to effectively perform simulated use tests, stress tests, etc. on new and modified products.
• Actively participates as a project team member in the development of new product specifications with particular emphasis on clinical acceptability and the ability of these specifications to be objectively verified/validated.
• Works directly with project teams, functional managers and Quality Assurance to investigate product design problems reported by customers and to effect resolution of those problems.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager