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Quality Engineer

position is located in Knoxville, TN and relocation assistance will be offered to the right candidate. Coordinates quality assurance programs to ensure procedures and systems are in place to maintain compliance to regulatory requirements for FDA and ISO standards. The Quality Engineer is responsible for developing, preparing the installation and/or revising of test validation procedures/protocols to ensure that the product is manufactured in accordance with the appropriate regulatory agency validation requirements, internal company standards and current industry practices. Analyses validations data, prepares reports, and makes recommendations for changes and/or improvements Maintains appropriate validation documentation and files Responsible for validating machines Works closely with manufacturing to ensure implementation of unique projects or processes Assist in investigations regarding product complaints to regulatory requirements and internal procedures and processes Coordinates written documentation updates and control of the updates Provides assistance in preparing and implementing procedures and specifications Works with manufacturing staff on quality related issues Performs inspection and approval of raw materials as needed Review batch records and receiving records as needed Serves as auditor internal audits Serves as auditor for supplier audits Requires a Bachelor's degree and a minimum of 5 years' experience in the Medical Device Manufactruing industry.   Salary for this position is $70,000 to $85,000

Everett (Massachusetts), Massachusetts