Software QA Engineer Mgr

Arthrex

About The Position

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. We are actively seeking a Software QA Engineering Manager with strong critical thinking skills and a passion for learning new technologies to support our Engineering teams. In this role, the Software QA Engineering Manager will lead and support a team of software quality engineers responsible for testing and performing quality analysis of application functionality. This work ensures that Arthrex business systems meet defined user requirements, function as intended, and comply with established quality management standards and regulatory expectations. The ideal candidate will collaborate closely with cross-functional engineering teams to promote software quality throughout the development lifecycle while helping drive continuous improvement in testing practices, tools, and processes. Strong communication skills, analytical thinking, and technical project management experience are essential for success in this role. Join our talented team at Arthrex, a global medical device company dedicated to Helping Surgeons Treat Their Patients Better™. Main Objective: Leadership and management of overall Software Quality Assurance activities and processes for the Arthrex ADI Team.

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
Experience in an FDA regulated environment preferred
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

Nice To Haves

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
PMP certification preferred

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