Senior Quality Engineer

Client Medical Device Company Employment Type Contract on W2 (US Citizens or GC holders only) Job Title Senior Quality Engineer Location Louisville, CO Duration 12+ Months Contract Description 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. Responsibilities Demonstrates intermediate knowledge of quality engineering policies, principles and best practices Demonstrates intermediate knowledge of FDA/ISO requirements Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity May act as mentor to less experienced team members Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision Writes 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. Additional Information For many roles at this client, assignment is contingent upon the Employer of Records receipt of sufficient proof that you are fully vaccinated against COVID-19 (meaning two weeks have passed after the last injection of Pfizer/Moderna or two weeks after receipt of the J&J). In some locations, weekly testing for COVID-19 may be available instead of vaccination. Requests for accommodation will be considered pursuant to applicable law. #J-18808-Ljbffr