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Posted: Sunday, August 27, 2017 12:03 AM


Quality System Specialist
Co-Diagnostics Inc
Bountiful, UT 84010

Job Description

We have recently completed our IPO and are searching for an experienced quality system specialist to oversee the maintenance and efficiency of our ISO 13485 Quality Management System, and assist with regulatory file compilations.

Specific responsibilities will include:

• Providing document control of quality management system.
• Formatting, editing, and ensuring signature and review of all documents.
• Maintaining files and backup of all QMS and Design History Files, which may involve ensuring that all employees uphold their own individual responsibilities regarding record generation and maintenance.
• Ensuring regulatory compliance and evaluation of suppliers and customers.
• Maintaining and compiling Company metrics.
• Assisting with document preparation, quality, regulatory filing and auditing schedules for ISO, FDA, and CE Mark.
• Performing related duties as assigned.


Qualified candidates will have experience with quality management systems. Preferred 5 years of experience with ISO13485 and FDA. Knowledge of basic Microsoft office software (Excel, Word, Powerpoint). Basic math and statistical skills a plus. Must be excellent at organization and multi-tasking. Good communication both orally and written. We are hoping to find someone whose entrepreneurial spirit and collaborative personality fits with our existing team and can grow within the company.

Additional Information

Please send cover letter and CV to

• Location: Salt Lake City

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