Job Title

Quality Applications Engineer- Somerset NJSummary 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 ply with Health, Safety, and Environmental responsibilities for the position.Adhere to company standards for data integrity and regulatory compliance.Education and Experience:Bachelors 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 requiredFamiliarity with FDA 21 CFR Part 11 compliance and data integrity principles.Proficiency in SQL, data visualization tools, and reporting platforms.