Overview

DTS is looking for a Quality Engineer for a long term contract position in West Chester, PA with one of our medical device client.The Supplier Quality Validation Engineer III provides overall quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of client products. They apply comprehensive and diverse knowledge of validations engineering principles and practices within broad assignment areas. Duties and Responsibilities:• Will provide complex team support for products that require validation at suppliers and external manufacturers.• Oversees Master Validation Plans for all suppliers and external manufacturers to provide input to client Management Review and Escalation Processes where required.• Partners with Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation and Verification strategies within suppliers and external manufacturers.• Ensure Process validation for integrated systems and automated equipment implemented as well as ensuring GAMP5, 21CFR Part 11 and 820 requirements are met.•Review/analyze whether current product and process, software and test method validations are in compliance to standards such as the QSRs, ISO 13485, etc. Addresses and corrects product and process issues during the review of validations provided by suppliers and external manufacturers.• Lead re-validation process as required due to engineering change, quality indicators analysis and/or upgrade in systems and material• Provide Leadership with the SQE team through the Validation Lifecycle•Champions compliance to validation regulations & standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements)Kindly send your resumes to engjobs@dts-it.com Contact Neeshi @ 248-438-8546