Quality Assurance Admin Assistant

Description

Under the direction of the QA/QC Manager, responsible for administrative support and ensuring that SLI obtains all necessary regulatory approvals and continues to maintain these approvals.

Requirements

* Associates degree or equivalent

* Bilingual in English and Spanish

* Good organizational skills and manual dexterity

* Understanding of medical terminology

* Accurate data entry skills

* Good verbal and written communication skills

* Working knowledge of Outlook, Word, Excel and Visio

* Valid driver's license, current proof of insurance, and clean driving record

Responsibilities

* Create and maintain facility registrations and any other licenses or required regulatory documents.

* Maintain a log of all regulatory licenses with appropriate renewal dates

* Researches regulations and standards for new and existing products to develop regulatory strategies

* Compiles regulatory submissions such as 510(k) filings, PMA, etc.

* Reviews CE Marking Technical Files to determine gaps and any necessary ongoing activities to maintain compliance to current regulations and standards

* Reviews Design History Files to determine gaps and any necessary ongoing activities to maintain compliance to current regulations and standards

* Identify and revise outdated established procedures and assist with revisions of established procedures

* Correspond with regulatory agencies and individuals by phone, email or fax as appropriate to follow-up on issues as requested

* Prepare monthly books for QMR

* Create project plans and act as project manager to implement plans in QA and RA

* Host facility regulatory inspections and follow-up action results

* Internet research as requested for regulatory issues

* Plan fire drills and conduct practical simulations

* Act as HIPAA Privacy Officer

* Follow-up on action items to comply with Safety Management System

* Ensure compliance with blood product lookback requirements

* Maintain a clean and organized work environment

* Regular, reliable and predictable attendance

* May perform other job related duties as assigned

* May be assigned to any Scantibodies location for any period of time

Job Benefits

We offer a comprehensive benefits package to include paid sick, vacation, medical, dental, vision, life insurance and 401(k).

Contacts

Email your resume to: View email address on click.appcast.io

Scantibodies Laboratory, Inc. is located at:

10946 Woodside Avenue North, Santee, CA 92071