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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 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, theFreedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, andFreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree.

+ A company recognized asa great placeto 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; drivetimelyclosure and sustainable outcomes.

+ **Author/redline complaint** **‑** **handling procedures** (SOPs/WIs/forms/trainings), manage change control, develop/deliver training, andmonitoradoption and effectiveness.

+ **Lead continuous improvement** of 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 data** to 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.

+ **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,TrackWiseor similar) and cross‑functional investigation workflows.

+ Demonstrated ability to **prioritize independently** , make sound regulatory decisions, and communicate clearly and professionally across functions.

+ Proficiencyin **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; experiencewith 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.

**Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email [email protected]