Specialist Quality Assurance job opportunity at Abbott.

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DateMore Than 30 Days Ago bot
Abbott Specialist Quality Assurance
Experience: 1-years
Pattern: full-time
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degreeAssociate
loacation United States - California - Alameda, United States Of America
loacation United States ..........United States Of America

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 your 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.   Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.   An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.       The Opportunity    This position works out of our Alameda, CA location. This is an onsite role.   The   Quality Assurance Specialist   is 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 change   control and   lead continuous improvement activities that enhance Abbott Diabetes Care’s post ‑ market surveillance complaint handling process. The Specialist partners cross ‑ functionally to implement durable fixes, improve   evaluation and   investigation quality and data integrity, and ensure the process   remains   inspection ‑ ready and aligned to FDA QSR, ISO 13485, ISO 14971, MDSAP, and EU MDR   and global   requirements . Secondary responsibilities may include supporting   complaint evaluations and quality reviews , trending and metrics, and audit/ inspection   readiness as needed.     What   You’ll   Work On   The primary function of the Quality Specialist is to   assist   in   maintaining   the quality system.   The role may include responsibility for one or more of the following processes    Own CAPA from initiation through effectiveness verification   for issues arising from complaint/PMS trends, audit/inspection observations, and process gaps; drive   timely   closure and sustainable outcomes.   Author/redline complaint ‑ handling procedures   (SOPs/WIs/forms /trainings ), manage change control, develop/deliver training, and   monitor   adoption and effectiveness.   Lead continuous improvement   of the PMS complaint handling proce ss (e.g., streamline workflows and templates, enhance coding taxonomies, improve data   quality   and cycle time, reduce backlog).   Trend and analyze complaint/PMS data   to detect signals; summarize findings and recommend/implement controls (e.g., quality holds, stop shipments) in partnership with   Global Customer Service,   Quality, Regulatory, Manufacturing/FA,   Track and Trend,   R&D   and 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 elevate   Complaint evaluation and   investigation quality, close knowledge gaps, and drive corrective actions.   Support new product introduction   (as needed) by providing complaint/PMS feedback to risk management and ensuring complaint codes, workflows, and training are in place.   Support complaint evaluation and closure activities , including complaint quality reviews and supplier quality reviews.       Required Qualifications   Associate’s degree   1 year of experience   Working knowledge of 21 CFR 803/820/806, ISO 13485, ISO 14971, MDSAP, EU MDR; strong GDP/GMP documentation discipline   Experience with a   complaint management system   (e.g.,   Salesforce,   TrackWise   or similar) and cross ‑ functional investigation workflows.   Demonstrated ability to   prioritize independently , make sound regulatory decisions, and communicate clearly and professionally across functions.   Proficiency   in   Microsoft Office   (Excel, PowerPoint, Word, Outlook).   Preferred Qualifications   3+ years of experience in medical device complaint handling and/or post‑market surveillance in a regulated environment     Proven process ownership for Complaint Handling (SOP/WI authoring/redlining, change control, training).   CAPA leadership (problem statement/scoping, root cause analysis, action planning, effectiveness checks).   Familiarity with   data trending and root ‑ cause methodologies   (DMAIC, 5 Whys, Fishbone) and basic statistics/SPC ; experience   with MAUDE searches a plus.   A detail-oriented individual with a 'can do' attitude and the ability to work in a team environment as well as individually (with minimal supervision).     Ability to work in a fast-paced environment with multiple tasks/projects.   Experience supporting   audits/inspections   as an SME.     Apply Now   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 $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.pdf       EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

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