QA Support Specialist
Fujifilm•Santa Ana, CA
•$31 - $35•Onsite
About The Position
We are hiring a QA Support Specialist. The QA Support Specialist will support external and internal requests for quality information. They will also help manage change notifications, surveys, qualifications, supplier management, audit corrective actions, and management of customer support related to Quality related questions.
Requirements
- BS/BA in Biology, Microbiology, or Chemistry
- 3-5 years of QA experience in medical device or biopharmaceutical environment
- Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR requirements.
- Excellent computer skills including MS Word, Excel, PowerPoint
- Ability to speak, read, and write proficiently in English.
- Good oral and written communication skills.
Responsibilities
- Helps customers obtain requested information (RFQ, master files, quality questions, investigations, certificates, trending, summaries, follow up, etc….)
- Acts as customer liaison for internal inquiries and provide voice of customer
- Coordinates customer surveys and questionnaires completion
- Assist with supplier questionnaires and qualification
- Assist with customer audits and follow up actions
- Assist with change notification and supplier management
- Assist with batch record review or other duties as needed
- Assist with coordination of quality activities for related FISI production site
Benefits
- Medical
- Dental
- Vision
- Life Insurance
- 401k
- Paid Time Off
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
