Post Market Surveillance - Quality
📋 Role Overview & Responsibilities
- Utilizes quality assurance system in compliance with current good manufacturing practice regulations.• Administers the change and Deviation and corrective action systems for assigned products and quality systems.• Supports the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely compliance evaluation of batch records, laboratory results and other cGMP documents.• Experience in Quality Systems (ISO 13485), Risk Management (ISO 14971), Auditing, Complaint Handling, Corrective, and Preventative Actions (CAPA)• Excel user comfortable creating pivot tablesEducation & Experience:• B.S. in Quality Assurance or Quality Systems with a minimum of 2 years of collective experience in a medical device required.• Experience in Complaint Investigation and assessing patient risk.• Assist with Post Market Surveillance department functions as needed.• Experience with manufacturing investigations, deviations, and CAPA.
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This position is located in Los Angeles Metropolitan Area with potential relocation and sponsorship assistance depending on candidate qualifications.
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