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QA Auditor

Company Name: Fujifilm Irvine Scientific
Location: Santa Ana, CA
Job Type: Full-Time/Exempt
Contact Name: P.J. Marcus
Salary: Depending upon experience

Job Description:

Irvine Scientific, a member of Fujifilm Holdings Corporation, is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. 

We are hiring for a QA Auditor. This Individual will perform and assist with internal, supplier, and customer audits, and will be responsible for coordination and completion of supplier qualifications and supplier questionnaires. The QA Auditor will ensure quality of business/manufacturing/supply chain through review of documentation in accordance to applicable regulations and standards.  This position is responsible for the management and handling of supply chain conformance and quality.  The QA Auditor will ensure quality is present through a review of all documentation in accordance with Standard Operating Procedures.  The QA Auditor also ensures compliance to ISO13485, QSR, Brazil, MDD 93/42, IVDD 98/79/EC, Canadian Device Regulations and other regulations as needed for the scope of internal audits.

Job Requirements: 

Responsibilities: 

  • Perform internal and supplier audits (on-site and paper)
  • Coordinate with internal personnel and suppliers to schedule, execute and follow up with audit observations
  • Performs supplier qualification
  • Complete customer and supplier questionnaires
  • Maintain audit documentation and completion of audit observations
  • Maintains supplier files
  • Assists with customer/regulatory audits as needed
  • Collaborates with other departments to meet customer requests 

Experience/ Education:

  • Bachelor's Degree in a scientific field of study (Biology, Chemistry, etc.)
  • A minimum of two (2) years of Quality Assurance in medical device manufacturer or equivalent
  • A minimum of two years in quality auditing for medical device or pharmaceutical companies
  • Proficiency in current versions of MS Word, Excel
  • Excellent communication and collaboration skills
  • Knowledge of current industry regulations, i.e. Detailed understanding of 21CFR211-cGMP, FDA QSR 820, ISO13485, Canadian Medical Device Regulations, Brazil and inspection and auditing guidelines 

For a complete job description and to review the requirements please visit: https://uscareers-fujifilm.icims.com/jobs/3751/qa-auditor/job?iis=OCRA