Senior QA Analyst, Analytical
FUJIFILM Corporation
Supplier Quality Engineer
Abbott
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $60,000 - $120,000 per year
Job Level
Junior
About the role
- Conduct supplier audits and develop/execute supplier audit schedules per current requirements
- Develop audit plans and associated supplier communications
- Approve and monitor Supplier CAPA plans and activities to closure including objective evidence of effectiveness
- Qualify new suppliers and monitor current supplier performance per site requirements
- Work with Design and Development, Manufacturing, Purchasing and IQA when qualifying and monitoring supplier performance
- Issue SCARs for supplier corrective/preventive action activities and analyze supplier information
- Present supplier metrics to appropriate CAPA boards
- Explain audit results and influence stakeholders; ensure regulatory compliance with ISO/QSRs
Requirements
- Associates Degree
- Minimum 1 year related experience in technical or other QA related positions in a regulated industry (preferred)
- Preferred: 5 years experience
- ISO lead auditor certification or equivalent is preferred
- Demonstrated writing and communication skills are required
- Thorough understanding of the ISO/QSRs and ability to apply that knowledge with an understanding of business operations to achieve regulatory compliance
- Knowledge of regulations and standards affecting in vitro diagnostic's device manufacturing
- Must be able to explain audit results and influence other's understandings of audit observations in a tactful and professional manner
- Must be able to handle supplier audit situations and interactions in a tactful, professional and effective manner
- Travel: Yes, 5% of the Time
