Software Verification Lead (Automation) - Qualitest Group

Are you interested in working with the world’s leading AI-powered quality engineering company? Ready to advance your career, team up with global thought leaders across industries, and make a difference every day? Join us at Qualitest! We are looking for a Software Verification Lead (Automation) to join our growing team in Indianola, PA, United States!

Role - Software Verification Lead (Automation) 

Location - Indianola, PA (onsite) 

Job Responsbility-

Primary Function
The Software Verification Lead is responsible for software verification and validation of our class II and higher regulated AI/ML SaMD products. The Software Verification Lead is provides guidance and support for non-senior and external Quality Assurance Engineers as well as Leads and is responsible for process improvements in the software verification area as well as in the software requirement area. Software verification comprise but is not limited to engineering of software verification and validation, requirement engineering, development of test strategy, deploy and maintain CI/CD (DevOps) pipelines along with execution and reporting of test.
 
TASKS AND RESPONSIBILITIES:
•Verification and Validation of software as a medical device including AI/ML based solution.
•Architect test strategy, development and execution of manual and/or automated software verification protocols, including
•Requirement analysis and review
•Architect test strategy
•Design and development of test scenarios
•Authoring and review of test cases and protocols
•Performing execution of test cases
•Analyzing results, tracking discrepancies, and writing reports
•Deploy and maintain CI/CD (DevOps) pipelines, including:
•Developing and maintaining Continuous Integration Deployment Testing infrastructure to accelerate product development cycle time
•Maintain test automation framework for medical device products
•Automating build creation and deployment, using Jenkins, AWS, and GitLab
•Scripting using Python, Perl, and other scripting languages
•Lead and manage verification and validation of complex AI software projects with cross functional teams distributed across multiple geographies under new product development (NPD) and/or Life Cycle Engineering (LCE) initiatives of ML/AI based Software as a medical device development, provide guidance and consulting to the team on technical and process issues, review deliverables of the team
•Fulfilling activities to comply with the project deliverables outlined in the Design and Development Plans and Design Control Procedures, as applicable.
•Compliance with standard operating procedures for medical device development, including compliance with ISO 13485, IEC 62304, IEC 82304 and FDA Design Controls CFR 820.30
•Individual contribution as well as managed activities involving verification planning, test execution and software integration.
•Critical analysis of technical situations to identify problems, and work with the cross-functional team in resolving the problems.
•Collaborating within cross-functional teams (technical lead, product manager, risk manager, software engineer, medical & clinical affairs and regulatory affairs) across multiple geographies to convey problems, opportunities, solutions, and results in software development activities
•Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function
 
Education Requirement:
•University degree (bachelor) in computer science or equivalent subjects

Skills & Competency Requirements:
•Minimum of 8 years or more of relevant work experience in software testing, software engineering, requirement engineering and/or risk engineering in healthcare software development or other regulated software development
•Minimum of 5 years or more of Test Architect experience in Software Verification in healthcare software development or other regulated software development
•Minimum of 5 years of V&V engineering and design controls in healthcare software development or other regulated software development
•Minimum of 3 years of Test Automation experience in Software Verification and Leading QA teams
•Minimum of 2years experience in DevOps activities
•Technical writing ability – clear and concise writing easily understood by multiple audiences (testers, developers, auditors, peers, etc.)
 

Preferences:
•Prior experience of working in Quality Systems Regulations with knowledge of documentation systems (i.e., Verification/Validation Protocols, SOPs) required of a business in the regulated industry
•Prior experience designing and developing medical device software in a regulated environment while adhering to FDA Design Controls and software process guidelines for medical devices including ISO 13485, IEC 62304, IEC 82304 and FDA Design Controls CFR 820.30
•Distinct conceptual and result-oriented thinking as well as customer orientation, high flexibility, and resilience
•Work experience in an international environment and fluent language skills (spoken and written) in English
•Knowledge of testing medical imaging algorithms and/or machine learning in the cloud
•Prior experience with scrum and test-driven development methods

Top must haves: (6-8 years exp)
1. Software V&V - V&V engineering and design controls in healthcare software development or other regulated software development
2. Test Architect experience in Software Verification in healthcare software development or other regulated software development
3. Maintain test automation framework for medical device products, Automating build creation and deployment, using Jenkins, AWS, and GitLab
4. AI/ML exposure/basics 

Benefits
Why QualiTest?

• Be a part of a company who strives to support for diversity and inclusion in the workplace – we are one, we are many at Qualitest. Celebrate culture, share knowledge with engineers from around the globe, and inspire each other through our differences. We have more than 40% women and around 120 different nationalities.
• Local and global opportunities – we offer you internal rotation and international mobility opportunities to grow your career.
• Clear view of your career and progression with the company – Qualitest is growing massively (since 2021 – tripled our employees base – we now have more than 8,000 engineers) and giving you the opportunity to grow with us.
• Work hard and play harder with our flexible and casual culture. Take a break from work and join an employee event, or enjoy the amenities and games provided from one of our Employees Centers.Save your earnings and prepare for your future by enrolling in our 401k plan where Qualitest will match your contributions accelerating your savings plan.
• Take care of health with enrollment into one of our competitive healthcare benefits. Qualitest will match towards your HSA if you choose to participate.
• Never stop experimenting and learning with QCraft – our Learning & Development platform: 50,000+ courses, 300+ virtual labs, mentorship and leadership programs, professional tribes, sponsored certifications, and much more.
• Stay active and get rewarded with our Corporate Wellness Program. We pay your Gym membership and giving you opportunities to Earn additional vacation times for attendance the gym!
• Earn bonuses via our Client Referral and Employee Referral Program’s. Refer and earn – tap your network for net-worth.
• We recognize our employees work via our Qudos platform - You can earn bonuses and spot awards by celebrating your and your peers’ achievements.
• Planning a vacation? Looking for car insurance? Get access to Qualitest Employee Perks for discounts on anything from travel to electronics. With so many offerings the savings are endless!
• A Competitive pay, the salary range for the role is $100,000 - $120,000.
• Intrigued to find more about us?
• Visit our website at https://www.qualitestgroup.com/
• If you like what you have read, send us your resume and let’s start talking!