• Provide support for quality system activities to assure conformance to established specifications and compliance to FDA 21 CFR 117/111 regulation and certificate standards. • Work on projects regarding external regulations, agency guidelines, and internal policies to assure compliance. • Facilitate the optimization and continuous improvement of internal quality systems to meet department and company objectives. • Ensure execution of day-to-day activities supporting supply chain, including release, testing, reviewing, troubleshooting and complete verifications/validations/calibrations as required. • Responsible for performance and KPIs through auditing, execution, follow-ups and management of non-conformances. • Responsible for identifying and escalating non-conformances and collaborating on issues. • Support operational excellence and continuous improvement activities across the site. • Collaborate with R&D, Production, and commercial teams in the development and preparation for production of new Products, Processes, and Equipment to support new product/customer launches.

• Quality Assurance Engineer III serves as an emerging individual contributor within a team, expanding your leadership, guidance and mentoring skills. • With the support and guidance of leadership, you will be responsible for supporting the goal of meeting scope, schedule and delivery requirements. • You will interact with stakeholders and utilize influential skills to drive improvements in engineering processes and practices. • Exhibits a comprehensive understanding of the business, how practices interact, and what customer problems we're solving. • Estimates, designs, and develops test cases as well as manual and automated testing with little feedback and guidance from their team. • Able to lead the development of a variety of test suites and partner with the team on including them in the software development lifecycle. • Anticipates coverage needed for automation tools and frameworks and proactively provides it. • Proactively writes boilerplate and exploratory test cases that cover unique or new functionality/ technology. • Able to extend program testing strategies to provide plans to teams for new functionality/ technology. • Participates in planning sessions, demonstrating understanding of overall testing strategy for the program, CI/CD delivery models, etc. • Actively participates in design and ensures building systems that are testable in the outset. • Supports recruiting efforts by evaluating homework assignments and potentially assisting with interviews.

• Manage and oversee a team of QA analysts with all management and leadership responsibilities • Monitor calls and conduct audits as necessary • Assist with the updating of SOPs, work instructions, checklists and various other documents under Quality management and document control • Managing and coordinating project deliverables, timelines and project assignments to ensure timely completion of assignments • Communicates quality issues to management and conducts root cause analysis with corrective and preventive action plans • Coordinates the logistics and conduct related audits, including sample selection, documentation, and communication of results • Assist with the calibration of quality monitoring results • Facilitate and or attend client calibration sessions to ensure consistency in the evaluation process - Training new QA analyst on proper auditing methods • Assist management with the administrative functions and coordinating Quality Recognition Programs, councils, and focus groups • Performs special projects as required, such as assisting with the development, research, and delivery of new trainings, or other duties when necessary • Assisting the management team and provide Quality support as necessary • Performs other duties or special projects as necessary

• Evaluate responses for factual accuracy and reliability • Apply structured fact-checking guidelines • Identify misinformation or unsupported claims • Deliver consistent, high-quality annotations