JOB DESCRIPTION:Supplier Quality Engineer IIThe Opportunity Structural Heart Business Mission: Why We Exist
Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.
Responsible for conducting supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers. Must be able to handle supplier audit situations and interactions in a tactful, professional and effective manner.
What You'll Work On• 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.
• ISO lead auditor certification or equivalent is preferred.
• 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.
• Work with Design and Development, Manufacturing, Purchasing and IQA when qualifying and monitoring supplier performance.
• 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.
• Demonstrated writing and communication skills are required for this position.
• 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.
• Must be able to explain audit results and influence other's understandings of audit observations in a tactful and professional manner.
• Knowledge of regulations and standards affecting in vitro diagnostic's device manufacturing.
Required Qualifications- Bachelor's degree in Engineering or Technical Field/related degree.
- Minimum of 5 years related experience in technical or other QA related positions in a regulated industry is preferred.
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is $81,500.00 - $141,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:SH Structural Heart
LOCATION:United States > Menlo Park : 3885 Bohannon Drive
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 10 % 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), Keyboard use (greater or equal to 50% of the workday)
