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 testing

• Authors, executes, and reviews test plans protocols, and reports to support product development

• Execute hands-on laboratory testing, data analysis, and technical investigations

• Collaborates with Design Engineering, Regulatory, and Laboratory staff to ensure testing activities are appropriately planned, executed, and documented

• Supports design controls, risk management, and other quality activities as needed

Responsibilities:

• Author, review, and execute TMV protocols and reports

• Develop and execute Design Verification plans, protocols, and reports

• Support hands-on verification and validation testing activities

• Analyze test data, document results, and communicate findings to project teams

• Investigate test failures, deviations, and nonconformances; support root cause analysis and corrective actions

• Ensure accuracy, completeness, and traceability of testing and validation documentation

• Review and approve quality and testing documentation in accordance with development procedures

• Support project teams and laboratory on quality-related activities

• Provide support for other quality activities, including design controls and risk management documentation