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| CAPA Remediation Consultant NC Open (J#45467) Title: CAPA Remediation Consultant Company: Iconma Description Duration: 6 months 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: - Drive CAPAs to closure through performance of effectiveness checks which may include focused internal audits, data analysis and/or observation of operations. - Work with CAPA owners to complete implementation activities including writing and editing procedures, associate training and initiation of change orders. - Lead investigation activities for newly opened CAPAs to include root cause analysis, documentation of findings and development of appropriate corrective actions and effectiveness checks. - Prepare documentation and objective evidence for all activities performed. Job Dimensions: - Must be able to work with and coordinate personnel from various groups including Quality Engineering, Operations and Technical Support / Service - Must have excellent written and verbal communication skills - Work independently in a fast paced operation including prioritization of responsibilities and timely completion of tasks. - Must have initiative, motivation, good judgment, ability to manage multiple tasks with frequent interruptions, and high attention to detail and accuracy. Supervisory Responsibility: - No direct reports, but will be responsible for coordinating personnel from throughout the organization to achieve program goals. Requirements - 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. - Minimum of 5 years experience in a Medical Device or other FDA regulated industry - Knowledge of data analysis tools such as Microsoft Excel or Minitab. - Attention to Detail .12 months - MS Excel ..12 months - MS PowerPoint - MS Word ..12 months Preferred Skills: - Previous experience managing a CAPA program in a medical device company - Six Sigma Green Belt - Experience with Track wise. Education: - Bachelor s Degree in a life science, engineering, or related technical field. - Advanced degree in a life science, engineering, or related technical field ..Preferred | |||
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