CAPA Process Analyst - Intellectt INC

Job Title: CAPA Process Analyst II
Location: Santa Rosa, CA
Duration:10+ Months
Shift: 8 AM - 5 PM

Key Responsibilities:

• Lead CAPA (Corrective and Preventive Action) investigations and ensure timely completion of activities.
• Facilitate cross-functional teams to determine root causes of nonconformities and ensure effective CAPA plans.
• Ensure CAPAs are implemented promptly for new or improved products, processes, and systems.
• Manage CAPA documentation to ensure audit readiness for internal and external audits.
• Produce reports and metrics to identify trends and initiate improvement actions.
• Prioritize workload based on business needs and ensure compliance with regulatory standards.
• Support the organization in achieving goals and ensure effective communication and teamwork.

Required Qualifications:

• Bachelor's degree in Engineering or Life Sciences.
• Experience with the CAPA process in medical devices or laboratories.
• Strong communication and technical writing skills.

Preferred Qualifications:

• Understanding of statistics, FMEA, and ASQ CQE certification.
• Knowledge of Quality requirements in CLIA, CAP regulations, or similar regulated industries.