Software Quality Assurance Engineer
5 days ago
Somerset
Quality Applications Engineer- Somerset NJ Summary of Essential Functions: The Quality Applications Engineer is tasked with supporting, maintaining, and optimizing digital quality systems and applications across the organization. This role ensures that all quality-related software tools are effectively implemented and aligned with regulatory requirements and business needs. The engineer collaborates with cross-functional teams to drive continuous improvement and system integration. Specific Duties, Activities, and Responsibilities: • Serve as the technical lead for quality system applications including QMS, LIMS, and document control platforms., • Configure, maintain, and troubleshoot quality software tools to ensure optimal performance and compliance., • Collaborate with IT and Quality teams to implement system upgrades, integrations, and enhancements., • Develop and maintain user documentation, training materials, and SOPs related to quality applications., • Support internal and external audits by providing system access, data retrieval, and documentation., • Analyze system data to identify trends and opportunities for process improvement., • Ensure systems meet GMP, GLP, and other applicable regulatory standards., • Provide end-user support and training across departments., • Participate in validation activities for new systems and upgrades., • Manage change control processes related to quality applications., • Comply with Health, Safety, and Environmental responsibilities for the position., • Adhere to company standards for data integrity and regulatory compliance. Education and Experience: • Bachelor’s degree in engineering, Computer Science, Life Sciences, or related field., • 3+ years of experience in quality systems or applications support within a regulated industry (pharmaceutical, biotech, or medical device)., • Experience with system validation and compliance documentation (IQ/OQ/PQ). Knowledge/Skills: • Strong understanding of GMP/GLP regulations and quality system requirements., • Hands-on experience with QMS platforms: MasterControl, Veeva Vault, LIMS and ERP required, • Familiarity with FDA 21 CFR Part 11 compliance and data integrity principles., • Proficiency in SQL, data visualization tools, and reporting platforms.