Responsibilities:

Perform Checker task in CCNs.To process Change Control Notifications in Windchill and GPDM systems.Review and route Change Control Activities (CCAs).Release changes in Windchill (CCN/DMC).Writes and implements CCNs/DMCs in Windchill system per procedure. Obtains proper approvals to change documents.Responsible for creating a placeholder for new documents on Windchill system or in GPDM.Tracks and distributes Change Control Notices (CCNs) to maintain trail of new and revised documentsto ensure compliance with regulations and SOPs.Perform Administrative Changes to correct errors or typos as indicated in procedure.Maintain the integrity of working documents and update documentation when revised.When necessary, will perform revision to the documents in the system.Assembles technical documents according to established procedures and guidelines.Implements and maintains standard operating procedures.Makes recommendations for improvements as necessary.Processes and performs approved changes to affected documents (including drawings, bill of materials, specifications, and product labeling).Update training in Compliance Wire.Upload and perform revision changes to documents in Compliance Wire system in accordance with performed changes through Windchill and GPDM systems.Responsible for controlling and updating approved organizational charts in SharePoint and in the local network folder.To assign Document number of procedures, validations, rework protocols, modules, visual aids, quality alerts, molding, and extrusion control numbers, etc.Update electronics logs.To maintain documentation databases updated.Review quality records. Update/Make corrections to Quality Records when required.This position may be required to support and respond to internal audit observations and corrective actions. Timely and proper response to these requirements will be tied directly to annual performance reviews.Maintains current knowledge of ISO 13485 (most current version) and GMP standards/requirements for medical devices to ensure compliance.

 

Qualifications:

Bachelor’s degree.Bilingual English / Spanish.1 – 2 years’ related experience.Good computer skills and software packages knowledge: SharePoint, Windchill System,GPDM, MS Office, MS VISIO, AutoCAD and SolidWorks.Good data entry skills. Databases (desirable).Bilingual (English-Spanish).