Software Quality Manager

What You Can Expect Manage software testing teams for manual & automated testing and analysis to identify defects, verify software requirements and prepare documents based on the company QMS and regulatory environment, and provide leadership to Software Test Engineers. Essential Responsibilities Manage SW verification and Software release strategy based on the USA FDA, European and Asia Pacific in a regulatory environment Provide leadership and supervision to testing teams on multiple projects, mentor, and manage a team of SW Test engineers onshore & offshore, overseeing daily operations, workload prioritization Plan schedules for formal cycle testing Guide test teams to prepare & execute test cases (manual / automated), prepare test plans and test protocols. Submit defect reports using defect tracking application and follow through on its resolution Prepare weekly test metrics and present report to SW director on a regular basis Participate in Defect Review Board and work with Software Quality Engineer to follow up on features & defects Ability to travel is required Verify all software systems comply US FDA’s 21 CFR Part 820 (QMSR) and IEC 62304 (Medical Device Software Lifecycle Processes) Collaborate with Software Development Team & Software Quality Assurance teams to follow the company Quality procedures Prepare Delivery of Software Master Test Plans, Test Protocols per formal testing cycles Ensure Testing cycles are executed on timely manners with sufficient resources Provide Support post-market for installation Continuous execution of Dry Run testing Support internal & external audit when required Support Manual Testing when required Verify traceability matrices linking user needs requirements, System Design specifications, and test cases Liaison between Software Development team, Software Quality Assurance team Collaborate with DevOps and Software Development teams to integrate manual and automated test suites into CI/CD pipelines while ensuring compliance with FDA and IEC 62304 requirements Familiarity with Test management tool such as Jira, Jama or equivalent and automation frameworks What Makes You Stand Out Deep understanding of FDA, ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management), IEC 62304 (Software Lifecycle), Cybersecurity (ANSI/AAMI SW96, IEC 81001-5-1, NIST), and EU MDR, Software in and Software as a Medical Device (SiMD/SaMD) Your Background Minimum of Bachelor's degree in Biomedical or Mechatronics or Computer Engineering, or a related field 5-8+ years of software testing experience, with at least 4+ years in a Lead or Managerial role within the medical device or a regulated industry. Has lead group of test engineers on multiple projects simultaneously Proficiency in Verification & Validation (V&V), Design Controls, Software Testing (SDLC), and Hardware Testing, Solid understanding of Medical Device in Design Control Experience in drafting formal requirements Solid understanding Risk Assessment & Mitigation process Proficiency in written and spoken English Travel Expectations 15-20% EOE/M/F/Vet/Disability #J-18808-Ljbffr Zimmer Biomet