Quality Engineer/Quality Specialist

Quality Engineer/Quality Specialist

Quality Engineer/Quality Specialist

Accentuate Staffing is working with a growing medical device company in the RTP area with potential for a lot of career growth.  We are hiring for a Quality Engineer/Quality Specialist.


  • Help create, monitor, and improve ISO 13485 and 21 CFR 820 quality management system (QMS)
  • Develop processes and write procedures to ensure regulatory requirements and business needs are efficiently and effectively met.
  • Manage or assist in the management of the following systems:
      • Corrective Action and Non-Conforming Materials
      • Training
      • Equipment validation, maintenance, and calibration
      • Complaints and Post-market Feedback
      • Internal and Supplier Audits


  • 4-year technical degree
  • 1-7 years’ experience in the medical device industry
  • Knowledge of ISO 13485 and 21 CFR 820
  • Experience with Product Lifecycle Management (PLM) or electronic Quality Management System (eQMS) preferred (Agile, Arena, MasterControl, Propel, etc.)
  • Experience writing SOPs and work instructions
  • Proficiency in Microsoft Office
  • ASQ certification a plus

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