Validation (TMV) Engineer Position Available In Miami-Dade, Florida

Job Title:

Validation Engineer Job Description The Validation Engineer is responsible for ensuring the accuracy, reliability, and compliance of inspection methods used in the manufacturing of medical devices. This role focuses on validating automated inspection programs in accordance with FDA, ISO, and ICH guidelines. The ideal candidate will have experience with automated inspection systems, including those integrated into Coordinate Measuring Machines (CMMs) and other measuring systems. Strong technical writing skills are essential for developing validation protocols, test scripts, and reports. Responsibilities Develop and execute validation protocols (IQ, OQ, PQ) for inspection methods, ensuring compliance with FDA, ISO, and ICH guidelines. Validate inspection programs for automated optical inspection systems, including CMMs and other measuring systems. Conduct risk assessments and define validation acceptance criteria based on statistical analysis and industry best practices. Collaborate with Quality, Engineering, and Manufacturing teams to ensure inspection methods meet product and regulatory requirements. Analyze and document validation results, authoring comprehensive reports and justifications for validation conclusions. Maintain validation documentation to support audits and regulatory submissions. Investigate validation-related nonconformances and recommend corrective actions as needed. Stay up to date with industry regulations and best practices for validation of automated inspection systems. Essential Skills Engineering Degree 5+ years of validation experience Experience with

IQ/OQ/PQ

Test Method Validation Technical Writing Familiarity with FDA, ISO, and ICH guidelines Proficiency in Minitab Quality Inspection experience Apply to learn more!