Quality Assurance/Quality Control (QA/QC) Associate and Document Control Job at Inspired Spine Enterprise LLC
JOB TITLE: Quality Assurance/Quality Control (QA/QC) Associate and Document Control
AREA OF RESPONSIBILITY: None
SUPERVISION RECEIVED: Reports to the VP of Operations
SUPERVISION EXERCISED: None
SUMMARY:
The QA/QC associate will be responsible for maintaining documents in the quality control program, issuing electronic signature approvals and proof-reading documents.
The QA/QC associate is responsible for assuring compliance with the QMS processes for the review, approval and filing of records regarding the purchase or manufacture of medical devices and the processing of manufacturing records to comply with device quality standards.
In addition to the document control process, the QA/QC Associate will be responsible for maintaining inventory in a controlled manner, packing, shipping and tracking the distribution of medical devices.
TYPICAL WORKING CONDITIONS:
Office and machine shop adjacent setting.
ESSENTIAL JOB FUNCTIONS:
- Proof-read and edit documents for Quality Management System
- Work with specialized software/system to administer document control
- Scan, Maintain and Organize certificates and records from deliveries, manufacturing and inspection
- Create and track purchase orders
- Maintain tracking matrix of ongoing quality processes and related documents
- Complete training and documentation as required for Quality Management System to maintain compliance with FDA and ISO regulations
- Organize files and folders in server to maintain structure
- Review records for accuracy and completeness
KNOWLEDGE/SKILLS/ABILITIES:
- Strong organizational skills
- Attention to detail is a critical skill for this position
- Fluent utilization of Microsoft Office Products
- Fluent utilization of Adobe
- Database input
- Google drive / File Stream
- Ability to establish and maintain positive and effective work relationships with coworkers
- Ability to exercise independent judgment and employ basic reasoning and self-management skills.
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