Requisition ID 22977BR
Division Reconstructive
Business Unit Hips and Knees
Country United States
State NJ
City Mahwah
Shift 1st
Job Description Divisional responsibility for the administration of the configuration management system. Review change requests to ensure that they meet defined requirements. Provide technical assistance, troubleshooting and training to users of the configuration management system. Prepare, schedule and conduct Enterprise Change Review Board meetings. Follow up on implemented change requests to ensure that the change was implemented as specified. Maintain records, status reports and metrics.
. Administer the Configuration Management process in accordance with document procedures.
. Review submitted change requests to ensure that they are completed accurately.
. Provide first level technical review of requests as it relates to Quality Management System requirements.
. Process change requests using the Windchill ECM system
. Provide assistance and training to users.
. Troubleshoot issues and provide direction in resolving issues with submitted change requests.
. Prepare, schedule and conduct Enterprise Change Request Board meetings.
. Follow up to ensure that the changes were implemented as specified.
. Maintain records, reports and metrics.
Qualifications:
. Demonstrated knowledge of Quality Management Systems: ISO 13485, Quality System Regulation 21 CFR 820 and Medical Device Directive.
. Demonstrated experience with change control systems.
. Demonstrated experience with Word, Excel, Visio.
. Demonstrated administration experience with electronic document management systems.
. Demonstrated ability to independently troubleshoot issues with electronic document management systems.
. Demonstrated ability to problem solve and manage multiple tasks while assisting internal customers
. Demonstrated organizational, verbal, written and communication skills.
. Demonstrated ability to provide a high degree of service to internal customers.
Education and Special Training Required:
Bachelor's Degree in Engineering, Business, Information Technology or related science field with training and experience in Quality Management Systems. Prefer formal training in business and/or technical writing.
Percent Travel Required 20%
