East Walpole, United States
over 1 year ago
Siemens US Talent Acquisition China expansion project Project Manager 1
This is an individual contributor position that requires an individual with knowledge/experience utilizing document management systems and processes in a regulated environment, e.g., IVD, Medical Device, Pharma, Biotech, etc. The individual in this role will be responsible for executing the documentation modification, translation and implementation activities among Siemens US cross functional team, Global Translation Service Team and China manufacturing facility. This individual will also act as an ECO coordinator for all the ECO related activities. This position is based in Walpole, MA and reports into the China expansion Documentation Workstream Lead, also based in Walpole.
In this role the individual will be responsible for coordinating China document management activities.
Specific responsibilities include:
- Serve as a point of contact for all ECO/artwork/SMN/labeling requests. Work with the requester to process the request and enter corresponding data in SAP ERP
- Execute the documentation transfer process and train new and junior team members.
- Track all the steps in documentation transfer process to meet the project timeline and compile KPI data to provide monthly/quarterly status report to management
- Work closely with Translation Agency to monitor and track document translation progress to meet the project timeline
- Review, edit and format documents to ensure compliance with GDP and formatting requirements
- Organize document source files and compile document metadata information to load documents through bulkload process.
- Coordinate document transfer activities with all project functions, e.g., Manufacturing, Technical Operations, Engineering, Quality, etc.
Required Knowledge/Skills, Education, and Experience
Experience: A minimum of 2 years in an FDA regulated environment, (e.g., IVD, Medical Device, Pharma, Biotech, etc.)
Education: A minimum of a 4 year college degree is preferred, although a combination of education/experience will be considered.
- Prior experience with SAP ERP
- Prior experience as document control admin and advanced working knowledge of electronic documentation system
- Advanced expertise in MS Office Suite, including Excel, Word, Powerpoint.
- Prioritization, attention to details, multitasking, organizational skills, timeline driven and self-motivated
- Must be able to work collaboratively with other project team members.
Preferred Knowledge/Skills, Education, and Experience
- Fluency in Chinese (Mandarin, simplified) is a plus.
- Prior experience with facility start-ups, or other major projects, e.g. documentation system implementation.
- Project management experience is a plus.