• 06-Mar-2018 to 05-May-2018 (CST)
  • Quality
  • Minneapolis, MN, USA
  • Hourly
  • 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.

The Quality Assurance Coordinator is responsible for developing, establishing, and maintaining Quality System procedures and records ensuring compliance to QSR/ISO requirements. Identify quality system activities required to complete projects, including development and/or commercial release of a product or product line. 

Duties and Responsibilities

  • Provide QA support for ARKRAY's Blood Glucose Data Management program and ERP software. Assist with implementation and maintenance of these software programs.
  • Participates in project launches. Support project teams to ensure activities are completed on time by managing quality plan task lists.
  • Be the TrackWise Specialist including assisting team with implementation and maintenance of TrackWise processes (CAPA, Change Control, Complaint handling), maintaining the Change Control Process, and supporting the Complaint Handling team with day to day functions, including data entry into TrackWise.
  • Establish and update Quality System processes and procedures in compliance with requirements for medical devices
  • Support the organization's quality compliance programs and strategies. Promote continuous improvement of systems, products, and services.   
  • Work closely with each business unit and functional team to support the establishment and maintenance of the quality system, procedures, work instructions and quality records.
  • Assist in day-to-day functions of the Quality Systems / Quality Assurance and Regulatory Affairs Department including general administrative work.
  • Support external audits and regulatory inspections.

Knowledge and Skills

  • High School diploma required, Bachelor's degree in technical or scientific field preferred. 
  • 3+ years related quality assurance, quality system experience or an equivalent combination of experience and education. Medical device experience required.
  • Ability to process technical information using sound judgment and providing clear rationale when making decisions
  • Knowledge of ISO/FDA requirements related to medical devices
  • Experience implementing, validating, and maintaining software programs preferred
  • Strong technical writing skills
  • Proficient in use of Microsoft Office
  • Good organizational, attention to detail and follow-through skills
  • Excellent verbal communication and customer interface skills

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

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