Abbott is seeking a Supplier Quality Engineer to work at their Temecula, CA location in the Vascular division to conduct supplier audits, qualify new suppliers, and monitor the performance of current suppliers to ensure regulatory compliance and quality of products.
Requirements
- ISO lead auditor certification or equivalent is preferred.
- A thorough understanding of the ISO/QSRs and the ability to apply that knowledge with an understanding of business operations to achieve regulatory compliance is needed.
- Knowledge of regulations and standards affecting in vitro diagnostic's device manufacturing.
- Demonstrated writing and communication skills are required for this position.
- Minimum 1 year related experience in technical or other QA related positions in a regulated industry is preferred.
- Associates Degree
- 5 years experience (Preferred)
Responsibilities
- Supplier Audits: Develop and execute to a supplier audit schedule 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 and then monitor supplier performance Per current requirements perform activities that will qualify new suppliers and monitor current supplier base to ensure the status of the suppliers is correct.
- Work with suppliers as needed to ensure their performance is acceptable per site requirements.
- CAPA: Through the supplier audits and internal issues with supplier product, issue SCARs for supplier corrective/preventive action activities.
- Analyze Supplier information and present supplier metrics to appropriate CAPA boards.
Other
- Travel: Yes, 5 % of the Time
- Medical Surveillance: No
- Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
- Degree Requirements: Associates Degree
- Equal Opportunity Employer: Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
