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Sr. Quality Assurance Engineer

Company: The Judge Group
Location: Franklin
Posted on: April 27, 2021

Job Description:

Location: Franklin, TN Description: Our client is currently seeking a Sr. Quality Assurance Engineer for a 12 month + contract.

Medical device or other highly regulated industry experience is needed.Description/Comment: ** MUST BE LOCATED NEAR Franklin - WILL BE GOING TO PLANT SITE TO WORK EVENTUALLY ** This role will be primarily responsible for integration and remediation activities related to a new acquisition. This role will be responsible for planning, directing, and coordinating preparation and implementation programs to ensure compliance with company's quality processes and procedures. Specific tasks include: --- Reviews and thoroughly understands product functional and design specifications. --- Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products. --- Designs or specifies inspection and testing mechanisms and equipment. --- Conducts quality assurance tests --- Performs statistical analysis to assess the cost of, and determine the responsibility for, products or materials that do not meet required standards and specifications --- Performs defect analysis utilizing experience in statistical quality process analytical methods --- Prepares and maintains a variety of reports; manages documentation control systems --- Implements changes to the quality management system through procedure and process updates --- Communicates and resolves QA issues with quality technicians on a day-to-day basis --- Performs validation activities including protocol/report writing, review and approval of such documents, and overall maintenance of program --- Prioritizes and manages multiple projects within design specifications and budget restrictions --- Investigates and thoroughly understands developments in quality assurance codes and standards ---Responsible for developing and implementing professional training --- Setting Daily/Weekly priorities --- Other duties as assigned by manager --- Has the independence and authority to perform required tasks to ensure all provisions of the quality system are metAdditional Job Details:Experience Required: --- Commitment to excellence and high standards --- Excellent written and oral communication skills in English --- Strong organizational, problem-solving, and analytical skills --- Ability to manage priorities and workflow --- Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm --- Acute attention to detail --- Demonstrated ability to plan and organize projects --- Proficient on Microsoft Office (Word, Excel, Project and PowerPoint) --- Proven ability to handle multiple projects and meet deadlines --- Good judgment with the ability to make timely and sound decisions --- Competent understanding of ISO 9001, ISO 13485 and GMP regulations --- Familiar with Design and Risk Control principles --- Creative, flexible, and innovative team player --- Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of drugs, devices and/or biological products --- Quality Engineer certification desired --- Basic PC skillsSkills/Roles: Quality Engineer, Intermediate, 5 years, Required Project Manager, Intermediate, 5 years, Preferred Ability to Multi-task, Intermediate, 2 years, Preferred Quality Control, Intermediate, 3 years, Preferred QA Concepts, Intermediate, 5 years, Preferred Contact: This job and many more are available through The Judge Group. Find us on the web at

Keywords: The Judge Group, Franklin , Sr. Quality Assurance Engineer, Engineering , Franklin, Tennessee

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