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Quality Engineer(FDA)

Tech Mahindra Ashburn, VA Contractor
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Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and or maintenance of products or services. The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.Demonstrates intermediate knowledge of quality engineering policies, principles and best practicesDemonstrates intermediate knowledge of FDA/ISO requirementsApplies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexityMay act as mentor to less experienced team membersApplies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervisionWrites test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended

Has in-depth experience, knowledge and skills in own job family Applies knowledge and skills to a wide range of standard and non-standard situations Works independently with minimal guidance Usually determines own work priorities Acts as a resource for colleagues with less experience

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