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Abbott · 13 hours ago

Specialist Quality Assurance

United States - California - Alameda

Full-time

Onsite

Entry Level

$82K/yr - $141K/yr

1+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Quality Assurance Specialist will focus on driving CAPA, maintaining procedures, and leading continuous improvement activities to enhance the complaint handling process within Abbott Diabetes Care.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

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

Qualification

Complaint Management SystemCAPA LeadershipRegulatory ComplianceData TrendingMicrosoft OfficeCross-Functional CollaborationDetail-OrientedProblem Solving

Required

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

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