ANNA LEE

• Team Leadership: Guide offshore QA teams in developing and implementing effective test plan and strategies including mentoring, providing feedback to improve testing skills and strategies
• Test Management: Oversee all aspects of software quality which includes establishing key performance metrics and ensuring that tests accurately simulate end-user scenarios
• Requirement & Impact Analysis: Evaluate software functionality and create test strategies and test cases to assess product quality
• Provide input on go/no-go decision for sprint release
• Defect Tracking: Take charge of defect management, closely monitoring and reporting issues using ADO throughout the Scrum sprints
• Cross-Functional Collaboration: Engage with across teams such as PS/TS, manufacturing, and service center within the Scrum framework to gain the product knowledge and create appropriate test methodologies
• Product Support: Investigate and troubleshoot production issues, providing workaround solutions when necessary.

· Spearheaded the verification and validation of the Android to Linux OS migration project for medical device software applications.

· Managed the QA process for 3M Food Safety Department's CleanTrace Hygiene Monitoring System and Molecular Detection System projects.

· Led the software design control for the Petrifilm Plate Reader project, ensuring alignment with technical and user requirements.

· Conducted comprehensive impact analysis to ensure software meets user needs and technical specifications in the medical device sector. Demonstrated expertise in Failure Mode and Effects Analysis (FMEA), Quality Management Systems (QMS), risk analysis, and compliance audits.

· Collaborated closely with regulatory teams to ensure adherence to industry standards in the development and testing of medical device software.

· Initiated and directed the entire process of software verification and validation for a new product launch, starting from the foundational stages

· Managed software validation initiatives, aligning with Standard Operating Procedures (SOP) and ISO standards, ensuring high-quality outcomes in medical device software development.

· Orchestrated comprehensive testing of web and desktop applications, integrating seamlessly with firmware and hardware, supplemented by proficient database testing using SQL Server Management Studio.

· Demonstrated leadership in project management, adhering to strict timelines while utilizing a blend of waterfall, iterative, and agile methodologies.

· Initiated and executed quality assurance process improvements, significantly boosting testing efficiency across various food safety platforms, with a steadfast focus on continuous improvement and adherence to regulatory compliance.

· Led a diverse QA team, managing both onsite and offshore members, to ensure thorough testing and quality assurance across projects.

· Conducted comprehensive Salesforce platform testing, including databases, dashboards, reports, alerts, and notifications, enhancing customer and employee portal experiences.

· Developed and maintained an automation suite using Katalon Studio, fostering a test-driven culture within the Ecolab commercial digital solutions team.