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Quality Engineer

Indianapolis 80K - 100K p/h Contract

Job Responsibilities

  • This role is crucial for supporting the organization in meeting both quality and production objectives
  • By employing an engineering approach, the Quality Engineer will work towards enhancing manufacturing efficiencies and ensuring that all product quality standards are consistently met
  • Act as a quality representative for assigned manufacturing areas and/or customers, ensuring compliance with customer requirements, and industry regulations, including FDA Quality System Regulation and ISO 13485
  • Support the Material Review Board process in collaboration with operations and engineering teams
  • Provide ongoing quality engineering support to operations, including risk management, development of inspection requirements, and investigation of complaints, non-conformances, and Corrective and Preventive Actions (CAPA)
  • Handle submission of documentation to customers for new product launches and requests for documentation on legacy products
  • Demonstrate commitment to continuous improvement by identifying opportunities and recommending enhancements to the quality system and manufacturing processes
  • Establish effective corrective action plans and lead in the implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements
  • Recommend test methods and statistical process control procedures for achieving required levels of product reliability
  • Participate in testing and data analysis, including capability studies and Gage R&R studies, to ensure new processes meet acceptance criteria
  • Leadership in developing quality-related processes and initiatives
  • Monitoring of complaint trends and data to escalate emerging issues appropriately
  • Implementation of effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements


Qualifications

  • Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering
  • 4+ years' of industry experience
  • Strong knowledge of quality tools used in the industry
  • Analytical and quantitative approach to problem solving
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