• 17-May-2017 to 16-Jul-2017 (CST)
  • Quality
  • Edina, MN, USA
  • Salary
  • Full Time

Medical, Dental, Group Life Insurance, Voluntary Life Insurance, Disability, 401(k) Plan, Flexible Spending Plans, Tuition Reimbursement, Paid Time Off (PTO) and Holiday Pay

Be involved with a company that is changing the lives of people across the globe.

ARKRAY is looking for a Quality Engineer to provide technical quality engineering support to our processes and systems.

Duties and Responsibilities

  • Manage all validation activities in compliance to ISO 13485 and 21CFR Part 820 by writing and executing protocols and summary reports, provide statistical analysis to support validations and inspection plans, and monitoring process effectiveness
  • Provide Quality Engineering support to manufacturing processes by performing risk analysis, lead continual improvement of systems, develop accurate and efficient means of measuring, testing and inspecting, evaluating and recommending process improvements for optimization and cost reduction utilizing Six Sigma and lean manufacturing tools
  • Provide support to CAPA related activities by facilitating Nonconforming Product and Material Review Board systems, completing Action Requests, corrections, CAR, PAR, and other duties as assigned
  • Provide technical guidance to Quality Control inspectors on inspection methods and techniques, day-to-day issues
  • Provide support for Quality Control related activities including initiating document change orders and perform 1st Proof and 1st Article Inspections
  • Provide quality or technical support to product development teams

Knowledge and Skills

  • Minimum 4 years experience in Quality Systems for medical products manufacturing, preferably medical diagnostics or devices. 
  • Proven experience with FDA GMP/QSR, ISO and other regulatory issues related to medical devices.
  • ASQ QE Certification desirable.
  • Proven proactive team-based skills.
  • Knowledge of manufacturing processes, procedures, and production equipment.
  • Experience with statistical process monitoring and data analysis software.
  • Ability to perform product testing and supply supporting technical documents.
  • Notable technical writing skills and communication skills.
  • Computer skills such as Word, Excel, PowerPoint, Project.
  • Bachelors Degree in related technical field.

ARKRAY is an Equal Opportunity Employer: minorities, women, veterans, and individuals with disabilities are encouraged to apply.

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