• Support software validation and verification efforts to ensure compliance with FDA regulations and industry standards (e.g., 21 CFR Part 11, IEC 62304, ISO 13485). • Own the quality approval process for software components, including documentation review and final release approvals. • Act as the subject matter expert (SME) and work with the software product team to maintain, refine and improve the processes (policies, standard operating procedures (SOPs), and supporting documentation) for this area of the quality system. • Partner with the software engineering team to implement and maintain a robust software quality management system. • Establish yourself as a trusted advisor to the Enterprise Applications team, with a problem-solving approach and a willingness to listen to the engineers and ensure the processes and documentation align with current regulations and best practices. • Support projects with the IT Engineering team to automate documentation processes based on agreed project plans. • Support the IT and Engineering teams following established service level agreements (SLA’s) and tracking key performance indicators (KPI’s). • Communicate project and compliance issues to Quality Systems Management and provide solutions to mitigate potential risks. • Develop and support the teams that execute validation protocols, test scripts, and traceability matrices to ensure software functionality, reliability, and regulatory compliance. • Provide expertise in risk management for software risk assessments. • Lead internal and external quality audits and investigations related to software validation and compliance. • Collaborate with cross-functional teams, including regulatory, engineering, and operations, to support overall non-product software lifecycle management. • Supports QA department to determine documentation needs. Establish and improve necessary document templates and guide staff to support project needs and maintain site compliance with good documentation practices and cGxP data integrity requirements. • Stay up to date with evolving FDA, ISO, and other regulatory requirements for product software quality and validation.

• Act as the final line of defense for the brand’s professional reputation. • Review multi-channel communications to ensure clinical accuracy, professional tone, and regulatory compliance. • Provide constructive feedback to clinical and operational teams to drive continuous improvement in communication. • Assist the QA Lead in developing standardized templates and "Best Practice" guides as the department expands. • Identify any potential red flags in communication that could lead to clinical risk or reputational damage.

• Define and execute tests by leveraging product specifications, designs, and known context. • Verify high and moderate risk changes prior to production release • Ensure that your teams maintain low bug:feature rates and low bug escape rates • Communicate effectively within both your embedded teams and the broader Quality organization • Track your findings and projects effectively by adhering to our QA processes • Perform Exploratory Testing Sessions • Participate and play an active role in daily scrums, weekly grooming sessions, and all sprint rituals • Verify reported bug findings quickly and reliably • Proactively contribute to overall process improvement initiatives • Perform root cause analysis on bugs that come in from production

• Develop, review, and provide guidance on comprehensive test plans and test cases covering functional, integration, regression, performance, and user acceptance testing • Validate Salesforce-based applications and integrations to ensure system integrity and reliability • Identify, document, track, and report software defects using enterprise issue-tracking tools • Collaborate closely with developers, business analysts, and project managers to resolve defects and maintain product quality • Clearly communicate test results, risks, and defects to both technical and non-technical stakeholders • Participate in design and requirements reviews to proactively identify quality risks • Ensure testing practices align with federal standards, healthcare regulations, and security requirements • Contribute to the continuous improvement of QA processes, tools, and methodologies • Stay current with industry best practices in Salesforce testing and software quality assurance