ISO 13485 Registered

Employment Opportunities

Quality Control Technician II   

Stellartech is looking for a Quality Control Technician to join our Team.

Responsibilities:

  • Prepare/assemble, review, and approve Device/Lot History Record (DHR/LHR) documentation to effect finished product release, to include Certificate of Conformance (CofC) issuance.
  • Maintain up-to-date DHR/LHR files, including electronic versions.
  • Prepare sterile disposable product for shipment to sterilizer, including all necessary / ancillary paperwork.
  • Assist in management of the equipment calibration/PM program, to include induction of new equipment into the program, sending equipment out for calibration/PM, proper documentation/stowage of inactivated equipment, and maintenance of records.
  • Assist in management of the Controlled Environmental Area (CEA), including scheduling service and reviewing & reacting to various reports/records -- e.g., environmental monitoring reports, product bioburden reports, cleaning records, and differential pressure monitoring records.
  • Perform final inspections, including Power-On-Self-Testing (POST) and visual inspection of finished medical devices prior to release.
  • Perform monthly electrostatic discharge control (ESD) tests and maintain ESD logs for Mfg, CEA, R&D, IQC, and stockroom.
  • Assist in maintenance & management of various QMS subsystems -- including, but not limited to Environmental Monitoring, Service Record Processing, Non-Conforming Material Handling, Manufacturing Deviation Authorizations, and Rework Orders.
  • Other duties as may be assigned.

Skills & Qualifications:

  • Minimum high school diploma.
  • An organized, analytical thinker with exceptional attention to detail.
  • An excellent communicator, both oral and written.
  • Capable of interpreting data, identifying root causes.
  • Working knowledge of Microsoft Office.
  • Working knowledge of 21CFR820 and ISO 13485.
  • 2-4 years of relevant work experience.

Salary:

  • Regular: $23.00/hr to $29.00/hr

To inquire about these opportunities, please contact us at jobs@stellartec.com

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