Quality Engineer (Test Method Validation)

Overview:Ensures compliance with applicable standards and regulatory requirements (e.g., FDA, ISO)Leads laboratory-based quality activities, including hand on experience with Test Method Validation (TMV), Design Verification (DV), and product testingAuthors, executes, and reviews test plans protocols, and reports to support product developmentExecute hands-on laboratory testing, data analysis, and technical investigationsCollaborates with Design Engineering, Regulatory, and Laboratory staff to ensure testing activities are appropriately planned, executed, and documentedSupports design controls, risk management, and other quality activities as neededResponsibilities:Author, review, and execute TMV protocols and reportsDevelop and execute Design Verification plans, protocols, and reportsSupport hands-on verification and validation testing activitiesAnalyze test data, document results, and communicate findings to project teamsInvestigate test failures, deviations, and nonconformances; support root cause analysis and corrective actionsEnsure accuracy, completeness, and traceability of testing and validation documentationReview and approve quality and testing documentation in accordance with development proceduresSupport project teams and laboratory on quality-related activitiesProvide support for other quality activities, including design controls and risk management documentation