The Technology Program Quality Assurance Engineer is responsible for executing and enhancing Quality Engineering activities for In-Clinic & Pharmacy Quality and Regulatory processes, with a strong emphasis on technology, systems integration, and data-driven decision-making.
Requirements
- Identify and prioritize opportunities to automate manual, repetitive, or error-prone processes across quality and regulatory workflows.
- Leverage modern tools (e.g., AI assistants such as Copilot, ChatGPT, Claude; low-code platforms such as Power Automate) to design and implement practical automation solutions that improve efficiency, accuracy, and scalability.
- Administer and optimize Quality Management Systems (QMS), electronic documentation systems, and integrated quality platforms to ensure data integrity, systems reliability, and regulatory compliance.
- Develop, maintain, and enhance dashboards, automated workflows, and data analytics tools to monitor quality metrics, identify trends, and enable proactive decision-making.
- Collaborate with IT and cross-functional teams to implement system integrations, automation solutions, and digital enhancements that improve QMS processes, quality operations and scalability.
- Support and enhance day-to-day applicable QRO processes by applying engineering principles and technical solutions to ensure compliance with regulatory requirements and internal standards.
- Work to identify opportunities and develop solutions to improve complex investigations related to complaints, Nonconformance Events (NCE), and CAPA, incorporating data analysis, root cause analysis tools, and system-based insights.
- Drive improvements in quality processes related to Recall management systems and traceability, Supplier quality systems and performance monitoring, Drug Supply Chain Security Act (DSCSA) compliance systems and data exchange, In-Clinic new item approval workflows and system enablement.
- Ensure quality systems and electronic records comply with SOPs, regulatory requirements, and data integrity standards (e.g., ALCOA+ principles).
- Design and maintain standardized documentation frameworks within QMS and related systems to ensure accuracy, traceability, and audit readiness.
- Identify systemic risks, data inconsistencies, and process gaps; implement technical controls and automated solutions to mitigate quality and compliance risks.
- Support internal audits, regulatory inspections, and system validations by providing technical expertise and ensuring system readiness compliance.
- Identify opportunities for process implementation of continuous improvement initiatives.
- Collaborate with QRO leadership, IT, Supply Chain, and other cross-functional teams to design and implement scalable quality solutions.
- Provide technical guidance and training to team members on quality systems, automated processes, tools, and data utilization.
- Complete all required training in accordance with established timelines
- Perform all other duties assigned to support quality and business objectives.
Benefits
- 401k savings & company match
- Paid time off
- Paid holidays
- Maternity leave
- Parental leave
- Military leave
- Other leaves of absence
- Health, dental, and vision benefits
- Health savings accounts
- Flexible spending accounts
- Life & disability benefits
- Identity theft protection
- Pet insurance
