Software Quality Assurance Manager

Home Dialysis Plus, Ltd.
Job Description
Job Title: Software Quality Assurance Manager
Department: Software
Reports To: Sr. Director, Software Engineer
Revision Date: May 18th, 2015
Classification: Exempt, Full-Time
Position Location: San Jose, CA
Position Overview
The Software Quality Assurance Manager will be responsible for ensuring software quality within complex
medical device products through the development and execution of software test protocols based upon
software and system specifications. This position requires a systems approach to problem solving and the
ability to understand complex electromechanical systems and physical processes associated with fluid flow
control.
Essential Job Functions
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Leverages experience and knowledge of systems design, software testing, and medical devices to lead
in the design and development of the software verification plans, protocols, and reports for HD+
products.
Provides project leadership for other SW test engineers in a multi-discipline environment.
Develops and communicates software quality metrics to the software development and test team to
provide insight into the overall software quality process.
Uses software metrics to develop predictive measures of software quality.
Review product design documentation to ensure that requirements stated are correct, unambiguous,
and verifiable.
Define test methods and create test plans for new or updated software projects to ensure that the
software will perform accurately and reliably according to documented requirements as well as
established standards under both normal and abnormal conditions.
Design and develop test protocols and scripts from the ground-up.
Perform test protocol execution and document results in test reports.
Analyze test results to assure quality of existing and new functionalities.
Consult with product development to evaluate system interfaces, operational requirements, and
performance requirements of overall system.
Recommend design improvements or corrections to engineers throughout the development process.
Monitor program performance after implementation to prevent reoccurrence of program operating
problems and ensure efficiency of operation.
Conduct compatibility tests with vendor-provided programs.
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Formulate and design software systems, using scientific analysis and mathematical models to predict
and measure outcome and consequences of design changes.
Participate in the continuous development of the QA Teams standard practices and procedures.
Create test tools that facilitate data gathering and test method execution.
Support manufacturing by verifying test fixture software or any software used during production.
Support clinical studies by validating data collection processes.
Home Dialysis Plus, Ltd.
Requirements/Qualifications
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Bachelor’s Degree in Electrical Engineering, Computer Engineering or equivalent technical Degree; or
equivalent combination of education and experience
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At least 5+ years of software test project and/or functional management experience in medical device
companies.
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Excellent analytical and analysis skills
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High level of initiative with ability to self-manage.
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Strong experience with automated test tools and white-box testing
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Strong interpersonal skills with ability to work both independently and as part of a team.
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Strong customer orientation
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Excellent written and verbal communication skills.
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Self-starter and detail oriented
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Must be self-managed, highly motivated, able to deliver work on time and complete to specification
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Ability to determine, understand and communicate clearly the validity, criticality, and scope of project.
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Prior software quality assurance experience in a product development environment
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Familiarity with FDA GMP
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Must be flexible, have the ability to work under tight deadlines, and support off-hours
deployment/maintenance as needed