Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Menlo Park, CA location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
As the Supplier Quality Engineer II, you’ll be 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 medical device manufacturing.
Required Qualifications
- Bachelor's Degree in technical/scientific area
- Minimum 2 years' experience in a Supplier Quality or closely related area
- Minimum 2 years' experience in a regulated industry
Preferred Qualifications
- Medical Device industry experience preferred
Apply Now
Learn 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. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$79,500.00 – $138,700.00
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:No
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Top Skills
What We Do
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
