Careers

QA Change Notification Coordinator

Quality Assurance | Santa Ana | CA

Job Function:
We are hiring a Quality Assurance Change Notification Coordinator. The Change Notification Coordinator will coordinate processing communication and qualification of external and internally generated material changes or process changes to customers. The person in this role will also back up QA staff for batch record review, raw material inspection, quality trending, and non-conformance coordination. The QA Change Notification Coordinator will also ensure customers are satisfied, and approve changes made or proposed by Irvine Scientific and its suppliers and affiliates. The person in this role will ensure quality is present through a review of documentation, labeling, and storage conditions of in-process and final product in accordance with Standard Operating Procedures, and ensures compliance to ISO13485:2003, QSR and Canadian Device Regulations.

 

Job Duties:

  • Coordinate processing, qualification and communication of external and internally generated material changes or process changes to customers
  • Communicate to customers any changes made by FUJIFILM Irvine Scientific, and answer any related customer questions
  • Coordinate with other departments to complete material qualifications
  • Review batch records and inspect labeling and storage conditions of product
  • Assist with maintaining the non-conforming material log, files and database
  • Assist in the preparation of all controlled documents (generating CRs as needed)
  • Review and improve processes as needed (provides training as needed)
  • Maintain Device History Records files and database
  • Collaborate with other departments to meet customer requests
  • Lot folder scanning
  • Review and verify all documentation in the batch record and maintain database for the QA Final Release History

 

Experience/Education:

  • High school diploma or equivalent required; basic understanding of mathematics and chemistry necessary
  • Two years of college in a science discipline is preferred
  • A minimum of two (2) years of Quality Assurance in medical device manufacturer or equivalent
  • Proficiency in current versions of MS Word, Excel, Outlook, PowerPoint
  • Computer skills
  • Strong communication/project management skills
  • Basic knowledge of Chemistry and related USP specifications
  • Detailed understanding of 21CFR211 – cGMP, 21CFR820 - QSR, ISO 13485, Canadian MDR, MDD-93/42 and inspection and auditing guidelines
  • Change notification and chemistry knowledge required
  • Excellent oral and written communication skills

 

Apply Now

 

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.

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