Job Description
Full Time Contract Role: Validation Quality Engineer Location: Onsite Dorado, PR Length of Contract: 6 months Position Description: The Validation Quality Engineer provides critical Process, Quality, and Validation Engineering support to manufacturing and product development teams. This role ensures compliance with FDA regulations, ISO 13485, and internal client quality management systems. The candidate will be responsible for authoring, reviewing, and executing validation protocols ($IQ/OQ/PQ$), identifying process defects, and managing risk assessments to ensure the delivery of high-quality medical devices. Responsibilities:
+ Validation Lifecycle: Author, review, and execute validation plans, risk assessments, and Equipment/Process Validation protocols ($IQ$, $OQ$, $PQ$) and final summary reports.
+ Risk Management: Develop product quality plans and lead risk management activities, including creating and updating Process Failure Mode and Effects Analy...
+ Validation Lifecycle: Author, review, and execute validation plans, risk assessments, and Equipment/Process Validation protocols ($IQ$, $OQ$, $PQ$) and final summary reports.
+ Risk Management: Develop product quality plans and lead risk management activities, including creating and updating Process Failure Mode and Effects Analy...