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Quality Assurance

  • Ref: 292061
  • Type: Option-to-Hire
  • Location: South Plainfield, NJ
  • Industry:
  • Job Level: Experienced Non-Manager
  • Pay: Negotiable

Opportunity Description

HumanEdge has partnered with a Global Device Company to hire an experienced Quality System/Regulatory Compliance (QS/RC) Technician for their first shift operations. 

Job Duties

The Role Responsible for:

  • The review and approval of processing files prior to product processing. The review ensures accurate product codes for numbers, case count, and cycle specifications. 
  • The review of processing files after product processing, and prior to product release, in order to ensure processing parameters have been met. 
  • Assists with the review of operating logs (spectrophotometer, gamma dose computational software log, pre-conditioning, aeration and maintenance) to ensure timely and accurate record keeping processes. 
  • Assists with the review and maintenance of calibration records to ensure calibration is performed properly and in a timely manner. 
  • Assists with writing deviations and documenting Customer concerns based on established Customer specifications and QS/RC policies and procedures.
  • With direction from the QS/RC Manager or Analyst, assists with corrective actions as required by process deviations, procedure deviations, complaints, regulatory audits, Customer audits, and internal audits.

 

Experience & Skills Required

Minimum Requirements: 

  • Associate’s Degree or equivalent training and experience. 
  • One or two (1-2) years performing Quality Technician level responsibilities and/or one to two (1-2) years of sterilization experience.