Quality Support 2

PDS TECH INC. is seeking candidate for Quality Support 2 position located in Walpole, MA.
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 assisting the documentation modification, translation and implementation activities among Siemens US cross functional team, Global Translation Service Team and China manufacturing facility.
In this role the individual will be responsible for coordinating China document management activities.
Specific responsibilities include:
? Coordinate document update activities with other project functions, e.g., Manufacturing, Technical Operations, Engineering, Quality, etc.
? Review and update documents format before sending them for translation
? Work closely with Translation Agency to monitor and track document translation progress to meet the project timeline
? Assign and track technical review/confirm with other project function SMEs after the translation is done
? Lead/participate in standing meeting with Translation Agency and internal functional SME (based both in US and China) to drive the activities to completion
? Compile KPI data to provide weekly/monthly/quarterly status report to management and escalate issues/risks
? Train/assist new documentation team members
? Final release and implementation of translated documents in China
Required Knowledge/Skills, Education, and Experience
Experience: A minimum of 3-5 years in an FDA regulated environment, (e.g., IVDD, Medical Device, Pharma, Biotech, etc.) with at least 2 years working as a document control coordinator/administrator role.
Education: A minimum of a 4 year college degree is preferred, although a combination of education/experience will be considered.
? Prior experience working in an FDA regulated environment and a thorough understanding of good documentation practices.
? Working knowledge with SAP PLM, SAP ERP, and Documentum or similar document management solutions (Agile etc.) and familiar with document control process workflow
? Knowledge of the SAP system, thorough understanding of change management process .
? Advanced expertise in MS Office Suite, including Excel, Word, Powerpoint.
? Excellent verbal and written communication skills.
? Prioritization, attention to details, multitasking and organizational skills
? Must be able to work collaboratively with other project team members.
? Ability to meet ever changing deadlines
Preferred Knowledge/Skills, Education, and Experience
? Fluency in Chinese (Mandarin) is highly desired
? Prior experience with facility start-ups, or other major projects, e.g. documentation system implementation.
? Prior experience working with translation services.
? Project management experience is a plus
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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