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 changes assuring correctness in documentation. Support laser products by assisting in the release of updates of BOMs/drawings and all product documentation through Agile Engineering Change Orders (CO)Communicates with Change Order Originators to make necessary corrections and additions to the change prior to routing the change for approvalRoute items for obsoleting, via CO (Change Order)Monitors direct actions and/or escalate issues regarding the change processing status to meet project release redlinesEnsure the approval requirements for the required change types, change category, lifecycle, and item type are implemented appropriatelyEnsure the data requirements for Agile and the applicable SAP fields are correctly implemented so that data passes to SAP correctlyResponsible for the final verification and entry of the effective date in Agile and SAPAnalyze and interpret data using independent judgment to approve, reject, release or rework changeInteract with cross-functional product development and diverse departments.Process quality system documentation, SOPs, Manufacturing instructions as well as other types of documentation releases such as design history files (DHF's)Manage design history files process by: Reviewing and releasing on the Agile system Certificates, Design Reviews, Confidential Documents, Protocols, Validations, Verifications, PRPs, Test Reports, Software Documents, and Technical files

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 Master Records (DMRs), Design History Files (DHFs) Lot History Records (LHRs), maintenance requirements.Medical Device, ISO 13485:2003Engineering Change Order (ECO/DCO) processingProcess Complaint Handling Reports and emails.

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 purchase orders for builds/ materials, obtain quotes, source new components, tracking pricing and lead-time, etc.Manage E&O and disposition of materialExperienced in Customer Service both external and internalTeam Center expert for data management and ECO releases

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, Manufacturing, Planning, IT, and purchasing groups to ensure transparency and consistency in the tracking systemPrepared process and status reports for Customer ManufacturesReview documents for accuracy and completeness

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 status and location of controlled drawings and procedures, maintained computer based files, assisted in implementing various QA/QC activities to support FDA-QSR/GMP compliance.

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 process development efforts to meet FDA guidelines.Review R&D (Research & Development) technical documentation to meet good manufacturing/lab/clinical practices.Work with ISO auditors on Non Conformance and CAPA activities.Manage the Calibration system by updating the database and assisting with technical reporting while also working with all group owners on calibration due items.Implement and maintain calibration activities with documentation and database management.In conjunction with suppliers, create service schedule and obtain price quotes.

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 records of related process development efforts to meet FDA guidelines, created PDF files of paper documents for manufacturing sites

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 numbers in PDM, performed SAP and PDM training with the Engineering Service Group, coordinated Change Control process with other BSC sites and external suppliers

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