Position title
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  • Identify and revise outdated established procedures and assist with revisions of established procedures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: hr@scantibodies.com
Scantibodies Laboratory, Inc. is located at:
10946 Woodside Avenue North, Santee, CA 92071

Job Location
9343 Wheatlands Rd., Santee, California, 92071, United States
Base Salary
$22 Per hour
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