Abbott
Product Recall Manager
Abbott, 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.JOB DESCRIPTION:
Working at AbbottA
t Abbott,
you
can do work that matters,
grow,
and learn, care for
your
self 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 e
xcellent 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 r
ecognized 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 OpportunityThis 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 i
nitiate 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
QualificationsBachelors Degree or an equivalent combination of education and work experienceMinimum of 7 years in Quality function.Comprehensive knowledge of executing Field Action documentation and notifications.Previous experience in completing Field Action packages.Cross-functional experienceSound decision-making skills contributing to high levels of competence, confidence, and credibilityThis position requires the individual to be on-site in Alameda, CA.Preferred
QualificationsMasters Degree Preferred.Familiarity with standards and regulations such as ISO 9001/13485, MDSAP, MDR/IVDRStrong and well-developed interpersonal communication skillsContinuous improvement methods and application, e.g., Lean, Six SigmaExperience 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
:
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.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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf#J-18808-Ljbffr
Working at AbbottA
t Abbott,
you
can do work that matters,
grow,
and learn, care for
your
self 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 e
xcellent 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 r
ecognized 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 OpportunityThis 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 i
nitiate 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
QualificationsBachelors Degree or an equivalent combination of education and work experienceMinimum of 7 years in Quality function.Comprehensive knowledge of executing Field Action documentation and notifications.Previous experience in completing Field Action packages.Cross-functional experienceSound decision-making skills contributing to high levels of competence, confidence, and credibilityThis position requires the individual to be on-site in Alameda, CA.Preferred
QualificationsMasters Degree Preferred.Familiarity with standards and regulations such as ISO 9001/13485, MDSAP, MDR/IVDRStrong and well-developed interpersonal communication skillsContinuous improvement methods and application, e.g., Lean, Six SigmaExperience 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
:
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.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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf#J-18808-Ljbffr