ARKRAY USA, Inc.
  • 06-Apr-2017 to 05-Jun-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 currently looking to fill a Quality Assurance Specialist position responsible for developing, establishing, and maintaining Quality System procedures and records ensuring compliance to QSR/ISO/CMDR requirements. Responsible for assisting in the development and execution of the Quality Systems including Internal Audits, Supplier Quality Assurance, Corrective and Preventive Action (CAPA), Quality Training, Complaint and Quality Data Trending.

 

Duties and Responsibilities

  • 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 with QA Manager to implement and maintain the internal audit program:
    • Develop an audit plan and tracking system.
    • Perform internal audits to ensure compliance with applicable regulations, standards, SOPs and established company procedures.
    • Investigate and resolve quality issues associated with audit findings.
    • Assist in implementing necessary actions to mitigate compliance and product risk.  
  • Assist QA Manager with supplier management program:
    • Review and approve vendors
    • Support the vendor certification program and participate in vendor scorecard for key performance indicators.
  • 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.
  • Quality System performance reporting to support Analysis of Data and Management Review meetings
  • Support the Complaint Handling team with day to day functions, including data entry into TrackWise.
  • Assist in day-to-day functions of the Quality Systems / Quality Assurance and Regulatory Affairs Department
  • 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.
  • Previous quality system audit experience required
  • Ability to process technical information using sound judgment and providing clear rationale when making decisions
  • Knowledge of ISO/FDA/CMDR requirements related to medical devices
  • Strong technical writing and presentation skills
  • Proficient in use of Microsoft Office
  • Ability to interface with a wide variety of organization functions
  • 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.

ARKRAY USA, Inc.
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