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:
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’llalso have access to:
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.
This position works out of our Alameda, CA location. This is an onsite role.
TheQuality Assurance Specialistis an independent contributor within the Complaint Handling Group whose primary focus is to own and drive CAPA, author/redline and maintain procedures (SOPs/WIs/forms/trainings) through changecontrol andlead continuous improvement activities that enhance Abbott Diabetes Care’s post‑market surveillance complaint handling process. The Specialist partners cross‑functionally to implement durable fixes, improveevaluation andinvestigation quality and data integrity, and ensure the processremainsinspection‑ready and aligned to FDA QSR, ISO 13485, ISO 14971, MDSAP, and EU MDRand globalrequirements. Secondary responsibilities may include supportingcomplaint evaluations and quality reviews, trending and metrics, and audit/inspectionreadiness as needed.
The primary function of the Quality Specialist is toassistinmaintainingthe quality system.
The role may include responsibility for one or more of the following processes
Author/redline complaint‑handling procedures(SOPs/WIs/forms/trainings), manage change control, develop/deliver training, andmonitoradoption and effectiveness.
Lead continuous improvementof the PMS complaint handling process (e.g., streamline workflows and templates, enhance coding taxonomies, improve dataqualityand cycle time, reduce backlog).
Trend and analyze complaint/PMS datato detect signals; summarize findings and recommend/implement controls (e.g., quality holds, stop shipments) in partnership withGlobal Customer Service,Quality, Regulatory, Manufacturing/FA,Track and Trend,R&Dand various other groups.
Prepare for and support audits/inspections(FDA,Notified Body, MDSAP, Corporate) as SME for complaint handling/PMS; ensure documentation is complete,accurate, and readily retrievable.
Collaborate cross‑functionally(Customer/Technical Support, Field Failure Analysis, Manufacturing, R&D, Quality Compliance, Regulatory, Clinical, Marketing) to elevateComplaint evaluation andinvestigation quality, close knowledge gaps, and drive corrective actions.
Working knowledge of 21 CFR 803/820/806, ISO 13485, ISO 14971, MDSAP, EU MDR; strong GDP/GMP documentation discipline
CAPA leadership (problem statement/scoping, root cause analysis, action planning, effectiveness checks).
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.
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:
ADC Diabetes Care
LOCATION:
United States > Alameda : 2601 Harbor Bay Parkway
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)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
