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. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO 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 Alameda, CA location in the Diabetes Care division where we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.
As the Product Recall Manager you will initiate and execute Field Action related activities and is a key contact for internal/external facing customers. Responsible for implementing and executing the Field Action process through completion. Supports team with managing and tracking responses to regulatory agencies and internal/external customers, when necessary.
What You'll Work On Prepare all Field Action documentation and issuance of Field Action packages. Develops strategies and project manages Field Action activities by working cross-functionally, then gaining approval from Senior Leadership. Independently completes Field Action documentation in a timely manner and in accordance with business standards. Works with the appropriate business functions to assess Field Action communication effectiveness as needed. Responsible for managing and tracking Field Action responses and updates to regulatory agencies, ensuring timely submission to the appropriate regulatory authorities. Responsible for compiling the Field Action documentation package and ensuring all documentation is complete and accurate. Acts as the Field Action subject matter expert for business audits. Responsible for managing and tracking responses to regulatory agencies. Project manages quality escalations and works cross-functionally with appropriate SMEs. Performs other related duties and responsibilities, on occasion, as assigned. Required Qualifications Bachelors Degree or an equivalent combination of education and work experience Minimum of 7 years in Quality function. Comprehensive knowledge of executing Field Action documentation and notifications. Previous experience in completing Field Action packages. Cross-functional experience Sound decision-making skills contributing to high levels of competence, confidence, and credibility This position requires the individual to be on-site in Alameda, CA. Preferred Qualifications Masters Degree Preferred. Familiarity with standards and regulations such as ISO 9001/13485, MDSAP, MDR/IVDR Strong and well-developed interpersonal communication skills Continuous improvement methods and application, e.g., Lean, Six Sigma Experience dealing with international locations and businesses
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* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
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.
The base pay for this position is
$109,300.00 - $218,500.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 2901 Harbor Bay Parkway
ADDITIONAL LOCATIONS: WORK SHIFT:
Standard
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), 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