Quality Engineer

  • Directs quality assurance activities for product introductions and validations.
  • Provides quality sustaining support for released production parts and activities.
  • Establish and update the Quality System based on changes to pertinent regulations, audit observations and changes to existing products and processes.
  • Manage and perform activities associated with CAPA, Complaints, Non-Conforming Materials, Risk Management, Sterilization Validation, Packaging, Biocompatibility Statistical Analysis, Inspection and Calibration.
  • Assemble reports, amendments, supplement, and letters to file to support Quality System compliance.
  • Develop and establish SOP' s according to regulatory requirements.
  • Oversees qualification and management of the overall Supplier base.
  • Lead others in the quality department through implementation and maintenance of the company quality system, reporting on the performance of the quality system for review and as a basis for improvement of the quality system.
  • Other duties as assigned.



REQUIREMENTS

  • Bachelors and/or advanced degree in a science or technical area or equivalent
  • 4-7 years related experience and/or training; or equivalent combination of education and experience.
  • Strong fundamental understanding of ISO 13485 requirements and/or ISO 9001
  • Profession knowledge of GDT, measurement analysis, and measurement systems.
  • Skilled at summarizing and analyzing data.
  • Skilled in tool, equipment, and product validation.
  • Skilled in risk assessment and analysis, i.e. flowcharts, pfmea, control plans, CAPA processing.
  • Medical device experience preferred
  • Six Sigma Black Belt certification a plus
  • A CQE is preferred but not required.



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