QA Auditor
5 days ago
We are hiring a QA Auditor. The QA Auditor performs and assists with supplier, distributor, and internal audits. They will be responsible for the coordination and completion of supplier qualifications, re-evaluation and maintaining the electronic supplier files.
Responsibilities:- Plan and perform internal, distributor and supplier audits (on-site, paper, and remote)
- Coordinate with internal personnel and suppliers to schedule, execute and follow up with audit observations
- Collaborate with other departments to meet the audit response proposed timelines
- Perform supplier qualification and supplier re-evaluations.
- Maintain audit documentation and completion of audit observations
- Maintain supplier files including, but not limited to qualification, re-evaluation, audit reports, and current ISO certification or applicable accreditations
- Assist with regulatory audits as needed
- Routine review of supplier activity for potential inactivation, future audits, and other actions such as SCARS initiation, or 'For Cause Audit'
- Assist with the development or maintenance of annual audit schedules
- Travel domestic and international as needed for supplier auditing
- BS/BA in Biology, Microbiology, or Chemistry required or equivalent science degree
- 2-3 years of QA experience in medical device or biopharmaceutical environment
- Proficiency in current versions of MS Word, Excel
- Excellent communication and collaboration skills
- Auditing experience highly preferred
- Current industry regulations, i.e., detailed understanding of 21 CFR211-cGMP, FDA QSR820, ISO13485, Canadian Medical Device Regulations, Brazil, EU and inspection and auditing
- Ability to speak, read, and write proficiently in English
- Good oral and written communication skills
- Able to travel 20-30% of the time domestic and international
- For California, the base salary range for this position is $79,954 - $104,236. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (fisihr@fujifilm.com).
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