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