Supplier Quality Engineer II

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 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Supplier Quality Engineer II Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. The 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 Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: 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 on Facebook at and on X @AbbottNews. 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) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: EEO is the Law link - Espanol: Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter