7785 - Senior Automation Test Engineer (Python)

Company: Qualitest
Location: Concord, California, United States
Type: Full-time
Posted: 11.JUN.2021

Summary

Description Are you interested in working with the largest independent software testing company? Read on!QualiTest is looking for a Senior A...

Description

Description Are you interested in working with the largest independent software testing company? Read on!QualiTest is looking for a Senior Automation Test Engineer in Concord, CA. This is a future pipeline role that is expected to open around Summer 2021. Establish validation standards and develop testing protocols Leading the development and validation of automated test and calibration systems for kidney dialysis systems Work with automation team and SQA Lead to define what to automate and who can do what. Document test results and maintain records for later analysis Coordinate and communicate between V team and other departments Compose reports and make adjustments to equipment or processes that require improvement Partners with and/or leads Business Teams and IT to ensure that computerized quality systems are compliant with corporate procedures, FDA Quality System Regulations, 21 CFR Part 11 and GAMP5 Creates and/or oversees the creation of validation deliverables including but not limited to Validation Assessments, Validation Plans, Test Plans, Test Protocols, Test Reports, test scripts, Validation Summary Reports and Trace Matrices, as needed to support local and enterprise system implementation in a regulated (FDA) environment Leads Business Owners/teams and IT in the definition and creation of Business Requirements, Functional Specifications and System Specifications as necessary Communicates project and compliance issues to Quality Systems management and provide solutions to mitigate potential risks Develops and manages Internal and External regulatory audits/ inspections by presenting and defending system validation projects and documentation during audits and FDA inspections as Subject Matter Expert Work with little to no supervision to fulfill duties in accordance with requirements of the QSR regulations, GAMP5, Corporate policies and procedures Follows all policies, guidelines, and SOP's as required Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results Provides assistance to other staff with complex tasks that require considerable judgment and initiative Requirements MUST have experience with software testing of a medical or embedded device (medical highly preferred) MUST have experience with developing automation frameworks, specifically using Python MUST have experience in a senior test engineering role (providing training and mentor-ship to other team members) Experience leading the development and validation of automated test and calibration systems for medical devices Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Provides assistance to junior staff with complex tasks that require considerable judgment and initiative. Mentors other staff as applicable. Benefits Why QualiTest? Have continuous access to and work with Senior Testing Specialists and Practice Experts Be a part of a leading testing company, globally recognized as a Visionary by Gartner Magic Quadrant Work with cutting edge technology in a company built by testers for testers, this is what we do! As a global company, we offer unique placement opportunities around the world Our QualiTesters are the reason for our success, we constantly encourage career development and promote from within Intrigued to find more about us? Visit our website at Check out our Career page: If you like what you have read, send us your resume and let's start talking!

 
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