Quality Assurance Manager

8 hours ago


Santa Ana, California, United States FUJIFILM Corporation Full time
Job Title: Quality Assurance Manager

FUJIFILM Irvine Scientific, Inc. is seeking a Quality Assurance Manager to oversee the communication of quality information to external and internal customers.

This role will be responsible for managing two main groups: QA Support and Audit Management.

The ideal candidate will have a strong background in quality assurance, with experience in managing audits, change notifications, and supplier management.

Key responsibilities will include:

  • Oversight of QA Support group and Audit management group
  • Coaching and training personnel within the group
  • Ensuring customer communication is completed fully and in a timely manner
  • Managing audits and ensuring actions are completed per agreed-upon timeframes
  • Reporting and tracking department activities to ensure KPIs are met
  • Assisting customers with obtaining requested information
  • Acting as customer liaison for internal inquiries
  • Managing customer surveys, issues, and questionnaires completion
  • Managing supplier questionnaires and qualification
  • Managing audit program
  • Managing change notification and supplier management
  • Assisting with coordination of quality activities for related FISI production sites

Requirements include:

  • BS/BA in Biology, Microbiology, or Chemistry preferred
  • 3-5 years of QA experience in medical device or biopharmaceutical environment
  • Minimum of 3 years management or supervisory experience required
  • Familiarity 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

Salary and benefits include:

  • $99,100- $129,100 depending on experience
  • Medical, Dental, Vision
  • Life Insurance
  • 401k
  • Paid Time Off

FUJIFILM Irvine Scientific, Inc. is an equal opportunity employer and welcomes applications from diverse candidates.



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