Sandra Collazo Email & Phone Number

Change Analyst (CA) to support Document Control by analyzing, verifying, releasing and implementation of Change Orders (CO) utilizing the Agile Software System and verifying transfer of changes in SAPThese changes will include product design changes, improvements, repairs, and new product development changesAnalyze the impact of proposed engineering.

Newark, CA

Support engineering documentation including Manufacturing Process Instructions/Method Sheets, Bills of Material, Travelers, Instruction for Use/User Guides and Service Instructions.Maintain records, files, drawings, procedures, documentation for regulatory purposes.Maintenance of FDA regulatory documentation(e.g. Device History Records (DHRs), Device.

Coordinate Build Scheduling with CM and project team for specific projects/platformPerform Business Management of CM and other supplier relationship (Contracts, SOW, etc)Procurement Experience to source components from printed circuits boards, electrical components, to mechanical and plastic piecesManage CTB (Clear to Build) ReportsTimely release of.

Livermore, CA

Maintained databases and logs for tracking part numbers, specifications, BOM’s, manufacturing build plan and other support systemsAssigned and implemented new part numbers in Agile and OracleCreated, processed ECN’s for Write non-technical documents and submitted into ECR/ECN system for approval and issuanceInterface with Quality, Engineering.

Physician/ Hospital Insurance ProcessingHIPPA RegulationsCMS-1500/ UB-04 Claim formsCPT/ICD/ HCPCS/ CodingMedical TerminologyMedical ManagerMedical BillingAnatomy/ PhysiologyLaw and EthicsOffice Procedures/ CorrespondenceData EntryAccounts Receivable/ CollectionsTyping SkillsTen Key SkillsMS WordTelephone/ Scheduling/ Filing

Support of Quality Assurance department including, processed ECO's, documentation control, scanning, filing, assisted in processing and implementing documents/change orders, set up and maintained files for engineering drawings, engineering change orders and/or other related documentation, scanned hardcopy files for electronic archiving, logged/ record.

Maintain electronic/physical copies of Design History Files (DHF) for all R&D projects.Deliver approved clinical and technical reports documentation to team members.Maintain Calibration.Develop updates and deliver weekly status of technical reports, calibration and clinical reports to project team members.Maintain documentation and records of related.

Supported R&D with the structure of the Design History Files (DHF), supported Project Managers with reviewing/formatting and obtaining approval for all the technical reports issued, developed updates and delivered weekly status of technical, calibration and clinical reports to project team members, assisted with Auditing, maintained documentation and.

Maintained document change control process via CRs in PDM, fulfill duties and assignments of PDM Coordinator, check quality of work of others in the same job level, verifying that specified changes were incorporated properly and to the highest levels of accuracy, prioritized business critical change requests, created finished goods documents and material.

Responsible for managing, coordinating, releasing, and communicating approved documentation, trained personnel on new operating systems, maintained online documents for users, maintained and archived documentation for reference, coordinated company partner documentation on company website

Responsible for viewing and transferring documents and data over to the ECO Matrix tool, edited and restructured data in the ECO Matrix tool, responsible for updating ECO report, responsible for sending weekly ECO report to Vendors

Education record

Education record