Abbott Laboratories
Product Recall Manager
Abbott Laboratories, Alameda, California, United States, 94501
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.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 be a key contact for internal/external facing customers. You will be 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.Develop strategies and project manage Field Action activities by working cross-functionally, then gaining approval from Senior Leadership.Independently complete Field Action documentation in a timely manner and in accordance with business standards.Work with the appropriate business functions to assess Field Action communication effectiveness as needed.Manage and track Field Action responses and updates to regulatory agencies, ensuring timely submission to the appropriate regulatory authorities.Compile the Field Action documentation package and ensure all documentation is complete and accurate.Act as the Field Action subject matter expert for business audits.Manage and track responses to regulatory agencies.Project manage quality escalations and work cross-functionally with appropriate SMEs.Perform 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.Apply Now*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.comFollow 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.
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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 be a key contact for internal/external facing customers. You will be 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.Develop strategies and project manage Field Action activities by working cross-functionally, then gaining approval from Senior Leadership.Independently complete Field Action documentation in a timely manner and in accordance with business standards.Work with the appropriate business functions to assess Field Action communication effectiveness as needed.Manage and track Field Action responses and updates to regulatory agencies, ensuring timely submission to the appropriate regulatory authorities.Compile the Field Action documentation package and ensure all documentation is complete and accurate.Act as the Field Action subject matter expert for business audits.Manage and track responses to regulatory agencies.Project manage quality escalations and work cross-functionally with appropriate SMEs.Perform 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.Apply Now*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.comFollow 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.
#J-18808-Ljbffr