Quality Assurance Specialist for Medical Devices

6 days ago


Maple Grove, Minnesota, United States Canon Recruiting Group Full time

Job Summary:

We are looking for a Quality Assurance Specialist to join our team at Canon Recruiting Group. The successful candidate will have a strong background in medical devices and quality assurance principles.

Key Responsibilities:

  • Develop and maintain quality plans, risk management plans and reports, hazard analysis, and product risk management workbooks.
  • Serve as a quality representative to improve awareness, visibility, and communication on quality initiatives.
  • Lead and support cross-functional root-cause analysis investigation and resolution activities.
  • Evaluate and support design test and inspection method development, and lead method validation activities.

Requirements:

  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering or Electrical Engineering.
  • 2+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience.
  • Strong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971), and software standards (IEC 62304 or IEC 82304).

About Us:

At Canon Recruiting Group, we are committed to creating an inclusive environment where all employees are celebrated for their unique differences.

Benefits:

  • A competitive pay range.
  • A comprehensive benefits package, including health care and 401(k) savings plans.


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