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QA Audit Supervisor

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 Audit Supervisor. This Individual will coordinate and manage the programs for internal, supplier, customer and regulatory audits. This includes scheduling, communication, execution, and follow-up of all actions associated with the audits. The QA Audit Supervisor ensures the company and suppliers adhere to high levels of quality. The person in this role will also budget, plan, execute, and follow-up with audits and auditors as needed to complete all audits on time and within expectations. The QA Audit Supervisor will collaborate with Supply Chain Management on the handling and assurance of supply chain conformance and quality, and will also ensure quality is present through all documentation in accordance with Standard Operating Procedures. The QA Audit Supervisor will ensure compliance to ISO13485, QSR, Brazil, MDD 93/42, IVDD 98/798/EC, Canadian Device Regulations, and other regulations as needed for the scope of internal audits.

Job Requirements: 

Responsibilities: 

  • Plan, budget, and coordinate auditors to ensure audit program is completed
  • Manage and perform internal and supplier audits (on-site and paper) as needed
  • Manage and perform supplier qualification
  • Manage completion of customer and supplier questionnaires
  • Manage maintenance of supplier files and documentation
  • Manage customer/regulatory audits: communication, execution, follow, and observation close out
  • Collaborates with other departments to meet customer requests and other demands 

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
  • A minimum of two years in a managerial position
  • 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
  • Filing necessary reports, applications for permits 

For a complete job description and to review the requirements please visit: https://uscareers-fujifilm.icims.com/jobs/3750/qa-audit-supervisor/job?iis=OCRA