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| CAPA Remediation NC Open (J#45589) Title: CAPA Remediation Company: NCG Description BASIC JOB PURPOSE: Perform activities required for investigation, implementation and effectiveness checks associated with the CAPA program. This includes limited focus quality system auditing, technical / operating procedure writing and analysis and remediation of quality processes. PRINCIPAL ACCOUNTABILITIES: 1. Drive CAPAs to closure through performance of effectiveness checks which may include focused internal audits, data analysis and/or observation of operations. 2. Work with CAPA owners to complete implementation activities including writing and editing procedures, associate training and initiation of change orders. 3. Lead investigation activities for newly opened CAPAs to include root cause analysis, documentation of findings and development of appropriate corrective actions and effectiveness checks. 4. Prepare documentation and objective evidence for all activities performed. Job Dimensions: - Must be able to work with and coordinate personnel RequirementsQualifications: QUALIFICATIONS REQUIRED- - Relevant professional certificates such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Regulatory Affairs Certification (RAC) or other ASQ certification may count toward 1 year of experience each. QUALIFICATIONS PREFERRED- - Advanced degree in a life science, engineering, or related technical field - Six Sigma Green Belt EXPERIENCE REQUIRED- - Minimum of 5 years experience in Quality Engineering or Quality Assurance within a FDA regulated industry. - Knowledge of data analysis tools such as Microsoft Excel or Minitab. EXPERIENCE PREFERRED- - Previous experience managing a CAPA program. - Experience with Trackwise. - Medical Device. REQUIRED EDUCATION- - Bachelor s Degree in a life science, engineering, or related technical field. PREFERRED EDUCATION- - Advanced degree in a life science, engineering, or related technical field No third party vendors. Must be citizen, green card holder or have EAD. Please send resume in word. | |||
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