Manager, Project QA - Abbott
Alameda, CA 94501
About the Job
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 AbbottAt 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) PPOAn excellent retirement savings plan with high employer contributionTuition 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 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 OnPrepare 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 QualificationsMinimum of 7 years in Quality function Experience with presenting to Executive Management Ability to project manage cross-functionally Highly organized during fast-paced environment Sound decision-making skills contributing to high levels of competence, confidence, and credibilityPreferred QualificationsPrevious experience in completing Field Action packages or understanding of Field Action processes 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 businessesApply 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: 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 Twitter @AbbottNews and @AbbottGlobal.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 SummaryJob number: 31098694Date posted : 2024-09-19Profession: QualityEmployment type: Full time
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 AbbottAt 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) PPOAn excellent retirement savings plan with high employer contributionTuition 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 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 OnPrepare 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 QualificationsMinimum of 7 years in Quality function Experience with presenting to Executive Management Ability to project manage cross-functionally Highly organized during fast-paced environment Sound decision-making skills contributing to high levels of competence, confidence, and credibilityPreferred QualificationsPrevious experience in completing Field Action packages or understanding of Field Action processes 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 businessesApply 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: 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 Twitter @AbbottNews and @AbbottGlobal.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 SummaryJob number: 31098694Date posted : 2024-09-19Profession: QualityEmployment type: Full time
Source : Abbott