Quality Compliance Consultant

SUMMARY OF POSITION:Support Quality Management during external audits from regulatory agencies. Coordinate required corrective actions and documented evidence in response to any non-conformances. Perform duties as an internal auditor which includes responsibility for evaluating Plant compliance through review of documentation, participating in team meetings, conducting audits of various processes, including assessments of all aspects of device production and distribution for compliance to FDA and International Quality System regulations, as well as Divisional and Plant operating procedures. Manage the CAPA process to ensure consistency throughout the plant.ESSENTIAL FUNCTIONS:1. Support Quality Management during external audits by regulatory agencies and for certifications, e.g. FDA, TUV, OEM, Suppliers.2. Coordinate required corrective actions and documented evidence in response to any non-conformances found during an external audit.3. Conduct internal compliance audits and provide written reports to management4. Conduct Compliance awareness training5. Provide Plant support in order to maintain compliance with all FDA and other U.S. and international regulatory requirements.6. Manage the CAPA process, including giving guidance for the originator, champion, and investigators as needed during the various phases of the CAPA process; assisting with QAAS system navigation when requested; and performing a final review of all CAPA’s prior to closure to ensure consistency throughout the plant.DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:1. Perform special projects, as directed2. Other duties as assigned with or without accommodation.Requirements: MINIMUM REQUIREMENTS:Education required/ preferred: A College degree and/or equivalent 2+ years experience in the Medical Device industry. Experience: Working knowledge of U.S. and/or European and international regulations and standards covering medical devices. Certified auditor. Preferred Skills/Qualifications: Excellent written and verbal ability with attention to detail. Strong organizational skills. Skills/Competencies: General knowledge of Word, Excel and PowerPoint.Other Skills: Team player and ability to serve on project teams, as needed.ORGANIZATIONAL RELATIONSHIPS/SCOPE:Job requires interaction with entire QA organization and other departments at all levels.WORKING CONDITIONS:Office environment.DISCLAIMER:The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.To apply online, please use the following link: Apply To Covidien Click here to see all “Covidien� opportunities Visit our web site to learn more about Covidien EMAIL THIS JOB TO A FRIENDCOVIDIEN, COVIDIEN with Logo and "positive results for life" are trademarks of Covidien AG. ©2007 Covidien AG or its affiliate. All rights reserved.