DQA Manager

Job Summary

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. This role leads, directs, and oversees pre-commercialization, design quality assurance efforts related to new products and product modifications within ZOLL's Research and Development organization.

Essential Functions

• 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.
• Develops test strategies, procedures and test setups needed to effectively perform simulated use tests, stress tests, etc. on new and modified products.
• 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.

Required/Preferred Education And Experience

• 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
• 5+ years' experience in a software design quality assurance leadership position required

Knowledge, Skills And Abilities

• Thorough understanding of software quality assurance principles, practices and metrics as well as software development and testing best practices that lead to high quality software.
• Hands on experience using modern software development and quality assurance tools.
• 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.
• Excellent written, verbal and interpersonal skills.
• Business acumen.

Pay

The Annual Salary For This Position Is $131,000.00 to $164,000.00. This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate.

Benefits

Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.

Application Information

Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location.

Equal Opportunity Employer

The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.