• 03-Jul-2018 to 01-Sep-2018 (CST)
  • Quality
  • Minneapolis, 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 currently seeking a Quality/CAPA Specialist to develop, implement and maintain Quality System processes, procedures and records, ensuring compliance to FDA and ISO requirements; and to be responsible for compliance to Corrective and Preventative Action (CAPA) processes and Medical Device regulations and requirements. 

Duties and Responsibilities

  • Manages the CAPA program by facilitating and monitoring all CAPA activities.
  • Oversees post market surveillance of currently marketed products through review of customer complaints, MDRs, Nonconforming Product Reports, PCRs, literature reviews, etc.
  • Manages the TrackWise program
  • Support the organization's quality compliance programs and strategies. Promote continuous improvement of systems, products, and services.   
  • Support internal and external audits and inspections for CAPA records and processes and other roles as needed.

Knowledge and Skills

  • 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
  • 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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