CAPA Process Analyst II

Our client, a leading organization in the medical device industry, is seeking a CAPA Process Analyst II to join their team. As a CAPA Process Analyst II, you will be part of the Quality Systems department supporting the Research & Development division. The ideal candidate will demonstrate strong analytical skills, excellent communication, and a proactive approach, which will align successfully in the organization.

CAPA Process Analyst II

Libertyville Township, IL (Remote work options available)

Pay Range not disclosed

• Lead investigations of nonconformances within the CAPA program, ensuring compliance with regulatory standards and internal quality policies.
• Develop audit-ready CAPA records in accordance with divisional procedures and support timely closure of investigations.
• Facilitate cross-functional collaboration to determine root causes and implement effective corrective and preventive actions.
• Partner with subject matter experts across R&D to ensure CAPA actions are aligned with organizational goals and compliance requirements.
• Track CAPA activities, manage due dates, and develop trending metrics to support leadership decision-making and continuous improvement.

• Bachelor’s degree in engineering or a related discipline.
• 4+ years of experience in CAPA, Quality Systems, or a related role within a regulated industry, preferably medical devices.
• Proficiency with root cause investigation tools such as 5 Whys, Fishbone, or 6
  
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• Strong technical writing skills and the ability to develop clear, audit-ready documentation.
• Excellent organizational, time management, and communication skills, with the ability to work independently and manage multiple priorities.

• Opportunity to contribute to innovative medical device solutions that impact patient health and well-being.
• Work in a collaborative and inclusive environment that values diversity and professional growth.
• Engage in meaningful projects that support continuous improvement and operational excellence.
• Flexible remote work options to support work-life balance.
• Be part of a reputable organization committed to ethical practices and industry standards.
• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay