Specialist Quality Assurance

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 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 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. 

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