Software QA Engineer Mgr (Remote)

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. They are seeking a Software QA Engineering Manager to lead a team responsible for testing and performing quality analysis of application functionality, ensuring compliance with quality management standards. The role involves collaboration with cross-functional engineering teams to promote software quality throughout the development lifecycle.

Responsibilities:

• Lead, develop and manage overall Software QA activities and SDLC workflow for medical device software applications
• Promote industry SDLC best practices
• Develop, maintain and approve QA processes to ensure the highest quality for product delivery
• Plan QA projects, balance QA resources, and maintain product quality metrics
• Understand product requirements and review test plans, scripts, and test cases written by the team members
• Participate in test script execution whenever necessary
• Review test results and release documentation
• Work closely with various application and software development teams to coordinate development and testing activities
• Work closely with software validation team to ensure processes are followed for all validated systems
• Participate as a key member of SDLC management and Arthrex leadership teams
• Ensure compliance within functional area and support the compliance objectives of the organization as a whole

Requirements:

• Bachelor's degree required: degree in Computer Science, Engineering or related field preferred
• At least ten years of experience in Software Quality Assurance, client server and web applications required
• Experience managing geographically distributed teams working on multiple concurrent development projects required
• Experience balancing QA resources between software development projects to meet strategic objectives and product management prioritization required
• Strong Project Management Experience required
• 5 years management or direct supervision experience required
• Hands on experience in thorough testing of application changes and implementations
• Experience analyzing Requirements, risk analysis and test development
• Experience in setting up QA Key Performance Indexes (KPI)
• Knowledge of Testing Center of Excellence (TCOE)
• Strong knowledge of the Software Development Life cycle and QA's role in it
• Solid understanding of several technologies including relational databases and SQL
• Demonstrated ability to document test plans, test cases, test results
• Documentation of test plan and test summary report
• Excellent communication skills and customer service orientation
• Experience using Product Lifecycle Management (PLM) software for medical device development
• Master's degree in Computer Science or MBA a plus
• Experience with testing custom cloud hosted, embedded, and SaMD applications preferred
• Working Knowledge of Atlassian, Xray Test Management, or equivalent Test Management tools preferred
• Experience in an FDA regulated environment preferred
• PMP certification preferred