Design Quality Assurance Engineer

Medical Engineering Consultants
Any Location, MN
Category Engineering
Job Description
Design Quality Assurance Engineer job opportunity with Medical Engineering Consultants, supporting development projects in the Cardiology division. Collaborate with cross-functional teams to evaluate design history files and provide quality and compliance input to project teams.

Requirements

  • Bachelors degree in mechanical engineering, Biomedical Engineering or related Engineering field of study
  • Minimum of 8 years of experience in design assurance, quality or related medical device or regulated industry experience
  • Experience in new product development: e.g. driving and creating risk management deliverables, risk management plan/report, hazard analysis, task analysis, dfmea, validating test methods, supporting the creation of design requirements, design verification and validation
  • ISO 13485, ISO 14971, CFRs and Quality System Regulations understanding and demonstrated use
  • Excellent organizational and planning skills and drives for results
  • Strong communication skills verbal, written
  • Demonstrated use of Quality tools/methodologies
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