Validation Engineer Position Available In Miami-Dade, Florida
Tallo's Job Summary: The Validation Engineer ensures inspection methods for medical device manufacturing comply with FDA, ISO, and ICH guidelines. They validate automated optical inspection systems, develop protocols, and collaborate with teams to ensure regulatory requirements are met. This role requires an Engineering Degree, 3+ years of validation experience, and technical writing skills. Onsite work in Kendal for a growing medical device manufacturer.
Job Description
Validation Engineer Job Description The Validation Engineer ensures the accuracy, reliability, and compliance of inspection methods used in the manufacturing of medical devices. This role involves validating automated inspection programs according to FDA, ISO, and ICH guidelines. Experience with automated optical inspection systems, including those integrated into Coordinate Measuring Machines (CMMs), is essential. Strong technical writing skills are required 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. 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 3+ Years Equipment Validation Experience
IQ/OQ/PQ
Vision system, CMM and/or other inspection equipment validation Test Method Validation Technical Writing Additional Skills & Qualifications Experience with Minitab Knowledge of Quality Inspection standards Work Environment This role requires onsite work. The company operates in two locations in Kendal, with one location in a high-rise building housing the Quality team, and the other in a two-story building with the doctor’s surgery center on the first floor and the design team on the second floor. The company is a rapidly growing medical device manufacturer with around 100 employees, and their device assists individuals who are severely injured.
