Abbott

Compensation

Full Description

Work options: Remote Title: CAPA Process Analyst II Location: Abbott Park, IL (Remote) Duration: 5 Months Position Overview Abbott Diabetes Care is seeking a contract position to support the divisional Corrective and Preventive Action (CAPA) program and ensure compliance with regulatory requirements and internal quality standards. This role leads investigations of nonconformances, facilitates root cause analysis, and ensures timely implementation of effective corrective and preventive actions to support the improvement of products, processes, and systems. This role will be responsible for managing the coordination of subject matter experts and development of CAPA records on behalf of the Research & Development organization. Key Responsibilities • Progress investigations and related activities through the CAPA program, ensuring timely and compliant closure. • Develop audit-ready CAPA records in accordance with divisional procedures. • Lead cross-functional teams in applying investigational tools to determine root causes of nonconformances and ensure CAPA plans address those causes effectively. • Partner with all subject matter experts within R&D to ensure CAPA actions support organizational needs. • Serve as a subject matter expert on root cause analysis investigation techniques (e.g., 5 Whys, Fishbone, 6M’s, etc.). • Ensure CAPA tasks are well-defined, justified with rationale, and attainable to complete. • Ensure corrective and preventive actions are attainable, measurable, and sustainable. • Track CAPA task and action due dates and coordinate with responsible individuals to ensure timely completion and closure of all activities. • Develop trending metrics for R&D leadership. • Identify improvement opportunities for CAPA communication and CAPA record development within R&D. Required Qualifications • Education: Bachelor’s degree in engineering or related discipline. • 4+ years in CAPA, Quality Systems, or related role within a regulated industry (medical devices preferred). • Experience using root cause investigational tools. • Proven technical writing capabilities. • Strong organizational and time management skills. • Excellent written and verbal communication skills. • Ability to work independently, manage multiple priorities and build relationships across functions. • Comfort with Microsoft Office Suite (Outlook, Excel, PowerPoint, Word). Consultants Eligible Benefits Upon Waiting Period • Medical and Prescription Drug Plans • Dental Plan • Vision Plan • Health Savings Account (for High-Deductible Health Plans) • Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit) • Supplemental Life Insurance • Short Term Disability (coverage varies by state) • Long Term Disability • Critical Illness, Hospital coverage, Accident Insurance • MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance • 401(k) 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, nutritional and branded generic medicines. Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.