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Quality Control Tech II
2 months ago
ESSENTIAL FUNCTIONS:
- 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.
EDUCATION AND EXPERIENCE:
- 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.
