**Summary**:Temporary position for Condor Project to perform all Document and Change Control activities as Change Analyst to maintain documentation and records of the Quality Management System in accordance with applicable requirements.
**Responsibilities**:Agile eDMS Control Analyst- Follows Document Control Procedure, check list of the Change Analyst and approval matrix.- Review and process changes on documents through the Document Change Orders (DCO) on Agile eDMS system.- Update and/or releases new documents and documents revisions.
(Procedures, Work instructions, forms, visual aids, operation sheets, etc.
)- Change analyst.- Maintains archive according to the record retention procedure.- Document translation- Participates in projects.Agile LPM Control Analyst- Follows Change Control Procedure, check list of the Change Analyst and approval matrix.- Review, control, monitoring, approve and release the ECO /MCO / DHF through Agile PLM,- Review and evaluate changes on specifications from originators.- Verification of documents updates- Releases Documents- Review Drawings- BOMs evaluation and update ERP System accordingly.- Maintains archive according to the record retention procedure.- Other duties may be assigned, as required.Trackwise- Use Trackwise System as required.
**Education**: Technician, bachelor's degree**Experience**:- 3+ year of experience in Quality Assurance Document Control area.- Knowledge: ISO 13485, 21 CFR part 820.
(Medical Devices Industry)- Software Systems related, such as Agile, Trackwise, Macola (desirable)**Languages**:English Level: 80 % minimum (Written and Speaking)****Skills**:- Service attitude, responsible, cooperative, dynamic, teamwork.- Ability to function in a multifaceted environment and balance multiple priorities simultaneously.- Strong computer skills including Microsoft Office with a focus MS Excel, use of software systems (Agile, Trackwise, Macola).- Attention to detail and ability to identify errors in the documentation.- Highly effective written skills