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• Identify and revise outdated established procedures and assist with revisions of established procedures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: ...

Scantibodies Laboratory, Inc. is located at:

10946 Woodside Avenue North, Santee, CA 92071