Project Manager I #JN -022021-60343

Description:

• Support Product Lifecycle Data (PLDM) team in delivering compliant change packages in an electronic data management system (SAP). Work closely with Engineering, Regulatory, Project Management, and other cross-functional teams to prepare Engineering Change Request (ECR) packages and support Customer Master Data functions

 Education/Experience:

• Bachelor’s Degree or equivalent
• 3+ years’ experience managing projects of varying complexity
• Proficient in Microsoft Office applications (Excel, Word, PowerPoint)
• Proficient SAP or equivalent. Knowledge of Configuration Management principles

 Material Master Management:

• Create and change material masters as required
• Extend part numbers into SAP to support multiple manufacturing facilities and engineering change activities
• Understand required settings to obsolete parts/ BOMs/ documents (including material implications)
• Provide guidance in trouble-shooting and driving resolution of Material Master issues

 Document Management:

• Review and approve documents for completeness and format accuracy prior to release
• Understand document signature strategies
• Complete document linkage at appropriate time
• Ability to decipher information from generated reports
• Review and approve Quality System Documents
• Ability to retrieve historical information from current and legacy systems
• Provide guidance in trouble-shooting and driving resolution of Document Management issues

 ECR/ECO Management:

• Support the creation of FDA compliant ECO packages for all changes of varying complexity including new product introductions utilizing Configuration Management principles
• Work in cross-functional ECO related activities in order to meet agreed upon deadlines
• Identify and assist in resolution of roadblocks preventing release of change notices
• Determine appropriate part numbers/BOM Structures prior to release (assist in BOM review activities)
• Support Pilot Run activities
• Support change notices in SAP (releasing parts BOMs and production documents)
• Ability to understand need and use for different BOM set ups (example: active, engineering, alternates)
• Ability to review ECR / ECO hierarchy / content and understand requirements and use
• Create and maintain lot tracking
• Ability to manage Electronic Device History Record activities, as needed
• Provide guidance in trouble-shooting and driving resolution of ECR/ECO Management issues

 Training:

• Guide and assist peers in job function areas as needed
• Facilitate training internal and external to the PLDM Department
• Contribute to the development of necessary training materials

 Project Management:

• Support ECO activities as described above

 Cross functional Support - Training Administrator duties

• Administer training to production associates
• Provide training materials to new hires, as part of an onboarding process
• Ensure production associates are trained to new changes to process / product
• Maintain updates to roles in Training Management System (TMS)
• Distribute & retrieve latest documents to production
• Notify production associates of changes and circulate for recertification
• Provide feedback to users on profile and training compliance and non-compliance
• Support users on using the Training Management System
• Establish, monitor and respond to metrics on the efficacy and efficiency of the Training Administration and Control activities and its ability to support the business