Quality Assurance Support Specialist

Quality Assurance | Santa Ana, CA

Job Function:

We are hiring a Quality Assurance Support Specialist. The QA Support Specialist will support external and internal requests for quality information. The person in this role will help to manage change notifications, surveys, qualifications, supplier management, audit corrective actions, and management of customer support related to Quality related questions. In addition, this person will ensure that customers obtain needed information to continue their process, and that required quality exists in audits and non-conformance program as prescribed by the FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, and Health Canada MDR requirements.

Job Duties:

  • Help customers obtain requested information (RFQ, master files, quality questions, investigations, certificates, trending, summaries, follow up, etc.)
  • Acts as customer liaison for internal inquiries and provide voice of customer
  • Coordinates customer surveys and questionnaires completion
  • Assist with supplier questionnaires and qualification
  • Assist with customer audits and follow up actions
  • Assist with change notification and supplier management
  • Assist with batch record review or other duties as needed
  • Assist with coordination of quality activities for related FISI production sites

Experience/Education:

  • BS/BA in Biology, Microbiology, or Chemistry preferred
  • 3-5 years of QA experience in medical device or biopharmaceutical environment
  • Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR requirements.
  • Excellent computer skills including MS Word, Excel, PowerPoint
  • Ability to speak, read, and write proficiently in English
  • Good oral and written communication skills

#LI-AA1

 

Principals only. No recruiters please.

FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

© 2021 FUJIFILM Irvine Scientific. All rights reserved.