• To gather genuine customer feedback • assess the entire process - from purchasing to receiving the book or eBook • evaluate its content - and share their insights with us

• To gather genuine customer feedback, we are looking for reader-testers to assess the entire process - from purchasing to receiving the book or eBook, as well as evaluating its content - and share their insights with us.

• 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.