Abbott · 1 day ago
CAPA Process Analyst II
United States
Contract
Remote
Mid Level
4+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The CAPA Process Analyst II will support the divisional Corrective and Preventive Action (CAPA) program, leading investigations and ensuring compliance with regulatory requirements while managing the coordination of subject matter experts and development of CAPA records.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
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
Qualification
Required
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)
Benefits
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)
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
2026-01-07
2025-12-31
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