QA Audit Supervisor
QA | Santa Ana | CA
We are seeking an individual to ensure the company and suppliers adhere to high levels of quality. Manage audit programs and the auditors to meet the requirements of the programs. Budget, plan, execute, and follow up with audits and auditors as needed to complete all audits on time and within expectations. Collaborate with Supply Chain Management on the handling and assurance of supply chain conformance and quality. Ensure quality is present through all documentation in accordance with Standard Operating Procedures. 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.
- Plan, budget, coordinate auditors to ensure audit program is completed.
- Manage and perform internal and supplier audits (on-site and paper) as needed.
- Manage and performs 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.
- High school diploma or equivalent; 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.
- 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.
- Current industry regulations, i.e. Detailed understanding of 21CFR211-cGMP, FDA QSR 820, ISO13485, Canadian Medical Device Regulations, Brazil and inspection and auditing guidelines.
- Ability to speak, read, and write English.
- Good Oral and communication skills.
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.