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Quality Engineer

2 weeks ago

Mayfield Village, OH, United States Norman Noble Full time

At Norman Noble we search for talented individuals who share our values, commitment to excellence, and who identify with our mission of meeting our customer's needs. We encourage all qualified candidates to review opportunities and apply for open positions.

Responsibilities and Duties:

  • Work with manufacturing to solve quality concerns and review, evaluate, and disposition non-conforming product
  • Analyze data and apply appropriate statistical tools to solve issues and determine outcomes.
  • Communicate (verbal and written) with customers and suppliers.
  • Aid in the maintenance and control of the quality management system specifically quality system documents (internal and external), quality system records, device history records, and final product release.
  • Works with Customers, Sales, and Engineering on validation & quality planning activities for new or existing programs.
  • Reviews drawings and recommends inspection and gauging methodology on new or existing programs.
  • Performs supplier quality audits (on-site and virtual).
  • Works as part as Supplier Quality Team to assess and evaluate existing suppliers for quality and performance, and to qualify new suppliers through evaluations, audits, and surveys
  • Coordinates 3rd party testing as part of regularly occurring testing on sampling basis.
  • Performs validation activities as part of supplier qualifications and changes.
Skills and Experience:
  • Quality engineering experience in med device, aerospace, or automatic manufacturing
  • CAPA experience/knowledge required, preferably in contract manufacturing or machining industry
  • Understanding of SPC, FMEA, DOE, inspection methods and equipment
  • Experience preparing, coordinating and executing validation activities including: IQ, OQ, PQ, SRS and MSV
  • Experience with QSRs, DHRs and final product release preferred
  • Knowledge of ISO 9001, 13485 and FDA QSR
  • Bachelor's degree in quality, engineering or related field required
  • ASQ, CQT, CQA and/or CQE certification is a plus
  • Strong analytical, project management and problem-solving skills
  • Organizational skills and have demonstrated ability to meet deadlines in fast-paced environment
  • Proficiency in Microsoft Office, with advanced proficiency in Excel


Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.