Specialist Quality Assurance

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. Youll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 bachelors 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 Cares postmarket surveillance complaint handling process. The Specialist partners crossfunctionally to implement durable fixes, improve evaluation and investigation quality and data integrity, and ensure the process remains inspectionready 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 Youll 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 complainthandling procedures (SOPs/WIs/forms/trainings), manage change control, develop/deliver training, and monitor adoption and effectiveness. Lead continuous improvement of the PMS complaint handling process (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 crossfunctionally (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 Associates 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 crossfunctional 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 postmarket 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 rootcause 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 Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter