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Quality Engineer
Ref No.: 17-03050
Location: Salt Lake City, Utah
Quality Engineer
Salt Lake City, UT
6 Month Contract

Job Description
  • This position is responsible for supporting the compliance activities to all applicable Federal, State and local regulations pertaining to GMP/QSR, ISO and associated regulatory agencies.
  • Assists with the implementation and improvement of all aspects of MCG SLC Quality System.
  • This includes all organizational excellence processes, quality improvement and compliance efforts for products / processes assigned by Quality Manager.
  • Support all functions surrounding/ensuring product quality for items assigned.
  • Assist with new Product Releases to assure they are accomplished timely and within all compliance standards
  • Assist in the development of proper inspection and disposition systems of product/components
  • Provide support in the deployment / maintenance and improvement of quality systems
  • Participate in compliance and continuous improvement of manufacturing processes
  • Assist with the implementation of quality management strategies and plans that assure the highest level of quality is met while maintaining deadlines and budgets
  • Develop and implement process monitoring, where appropriate
  • Conduct process audits
  • Develop / Review applicable process documentation
  • Assist with equipment calibration and audit equipment preventive maintenance
  • Assist with initiatives in continuous improvement and organizational excellence using suitable lean, six sigma and/or other alternate approaches
  • Participate in Product Development activities
  • Approve and support design and process verification and validation protocols
  • Approve and support software verification and validation protocols
  • Develop component and product inspection criteria are established for assigned products
  • Assist with qualification and auditing of suppliers
  • Ensure product compliance to standards during development
  • Perform and/or support risk management activities
  • Develop product quality plans
  • RA/QA representative on design reviews
  • The ability to rapidly acquire detailed knowledge of the specific systems used at MCG
  • Knowledge of QSR, ISO9001, ISO13485 regulations and lean manufacturing principles
  • Personal drive and follow through, strong human relations and team building skills
  • Able to succeed in highly regulated compliance oriented environment while still providing service excellence
  • Experience with Quality Management Systems
  • Strong computer knowledge, including Microsoft Office & Minitab
  • Support implementation, maintenance and operation of an effective Corrective and Preventative Action (CAPA) system.
  • Support implementation, maintenance and operation of an effective Non-conforming (Client) material program.
  • Support implementation, maintenance and operation of an effective Calibration system.
  • Support regular reporting on the performance of company quality metrics and corrective and preventative actions.
  • Complete all assigned CAPA, Client and other tasks in a timely manner.
  • Complete required training in a timely manner
  • Assist other Quality staff with their duties as requested
  • Assist with other projects as requested by a member of management
  • Assist in the development, implementation and attainment of "Key Performance Indicators” (KPI)
  • BS degree in Engineering or related field or 5 or more years of experience with Quality Assurance Engineering; or equivalent combination of education and experience.
  • ASQ Certified Quality Engineer and/or Auditor certification
  • Green or Black Belt Six Sigma Certification