Inginaire - Engineering Staffing

Quality Assurance Manager

St Paul, MN
Contact For Rate
Jul 12, 2017
Jul 19, 2017
Job Type
Employment Status
Full Time
Direct Hire position!
  • Maintain effectiveness of Quality Management System and compliance with ISO/FDA regulations
  • Ensure the effectiveness of quality control acceptance and release activities
  • Manage sterilization program, test labs and supplier quality
  • Manage drug/pharma quality control and analytical test activities
  • Manage bioburden and environmental monitoring and data analysis activities
  • Maintain quality performance metrics and oversee improvement activities
  • Support sales with customer quotes for products and services
  • Lead supplier qualifications and monitor ongoing performance
  • Lead corrective -action, nonconformance and complaint investigations
  • Review/approve document changes, equipment and process qualification and validation protocols/reports
  • Assist with tasks as needed/ requested by supervisor

  • Bachelor's degree in Engineering or Science discipline is required.
  • Certified Quality Engineer (CQE) or equivalent RA/QA certification in the area of regulated healthcare products is preferred.
  • Statistical Process Control (SPC) and Lean Six Sigma training is preferred.
  • 5-7 years managing quality assurance working in a medical
  • FDA (CFR 820, 210 and 211), and ISO 13485 quality management systems experience is required.
  • Process Failure Modes and Experience with the application of ISO 14971 for process FMEA and process validations (IQ/OQ/PQ) to mitigate risks is preferred.
  • Data analysis and writing technical reports using Microsoft Office and analytical software such as Minitab is preferred.

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