About the job Important international company is looking for a Validation Engineer with experience in the Medical Devices industry. (9 month project with the possibility of extension) Technical/Functional Skills Knowledge of Medical Equipment manufacturing processes GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 9000 and regulatory affairs Ability to specify & qualify Assembly, Tooling, Gage equipment and Fixture equipment Knowledge in the areas of Process validation, Statistical process control, Product design & DFMA (Design for Manufacturing & Assembly), Plastic & metallic materials & processing and Applied Statistics Knowledge of drawing software system such as AutoCAD and Solidworks. Demonstrated ability to interpret the engineering drawings i.e., GD&T (Geometric Dimensioning &Tolerancing) Knowledge of productive processes. Ability to work and interact with co-workers to accomplish company goals in a team environment Ability to work in stressful/fast paced environment Responsibilities: Conduct meetings to develop strategies and solutions with a cross functional team Can guide on the Validation process, lead the draft and review of protocols and test reports Can offer onsite support during the execution phase of validations (IQ, OQ, PQ). Can draft Validation Strategy, including TMV's Can qualify first articles, complete process capability studies & process validation on both internal & supplier processes using appropriate statistical techniques Can support change management activities using organization PLM tool Prepare reports as per project requirement Can supervise, coordinate and technically revise the work of a limited group of technicians. Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition Responsible for communicating business related issues or opportunities to next management level Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Etc.
