General Information:
Company: Sontec Instruments, Centennial, CO http://www.sontecinstruments.com/
Location: 7248 S. Tucson Way, Centennial CO,
Hiring: Quality Control and Regulatory Specialist
Overview
- Quality Control and Regulatory specialist needed for a small surgical instrument company in East Centennial selling class 1 and class 2 instruments both domestically and abroad.
- This is a part-time contract position that allows for flexible weekly office hours, while also coordinating with our senior FDA analyst, in order to make sure all documents and procedures are up to date.
- Hours will increase and decrease as needed but it is anticipated that 15-20 hours a week will be needed on average.
The ideal candidate will possess the following:
- Working knowledge of FDA regulations, ISO 13845 and CE that specifically pertain to surgical and CFG’s.
- Working knowledge of device classification and listing within the surgical instrument and medical devices and surgical instruments and the ability to research new shipping areas as needed.
- The willingness and ability to maintain a strict quality calendar of meetings and internal audits to comply with FDA and ISO quality standards.
- The willingness and ability to complete all paperwork, spreadsheets and documentation necessary to keep all systems up to date on a weekly basis and submit reports to the VP of Operations monthly.
Please reply with your resume and salary requirements to: dscanlan@sontecinstruments.com
