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CAPA Process Analyst II

1 month ago

North Chicago, United States Ziprecruiter Full time
CAPA Process Analyst II North Chicago, IL 6 months Contract Main Responsibilities: Leads the investigation of complex and highly technical quality issues to ensure the timely completion of CAPA system activities raised for nonconformances, potential nonconformances, CAPAs, deviations, and/or complaint investigations. Is a subject matter expert on investigation and root cause analysis techniques to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance. Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area. Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner. Produces trending metrics and reports to identify, prioritize and manage further actions, as may be required. Provides leadership for the initiation of improvement activities associated with identified trends. Is an active leader supporting a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements. Ensures effective written and verbal communications. Skills: Knowledge of the Corrective and Preventative Action process in medical devices Understanding of statistics Experience with medical devices which have reagents, complex electro-mechanical and optical components Education: Bachelor of Science in a life science or engineering discipline. Company Description: About Kyyba: Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances. At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development. J-18808-Ljbffr

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