Angel Culebro Email & Phone Number

Tijuana, B.C., Mx

1. Management and supervision of professionals with multiple engineers (SQE and Project Engineers) who are focused on a supplier's programs and some strategic activities within the SQE area and projects.2. Planning and Execution: I lead the team in planning and executing projects (Supplier Quality Systems) from start to finish.3. Quality Assurance: I make sure our products meet high standards by developing and maintaining quality control systems.4. Documentation and Coordination: I keep track of all project documentation and work closely with suppliers to ensure everything runs properly and according to the regulation.

Tijuana, Baja California, Mexico

Responsibilities:•Migration / integration coordinator per-Baxter Acquisition.•Change Control (Quality Systems Documents and Engineering Change Request) manage the document control program and administration of the plant documentation, (Controlled Copies, DHR and the control of the records storage and retention)•Assist in the investigation and resolution of nonconforming events and CAPA projects (Trackwise 8)•Complaints Trending Data Management and dashboard follow up (ETQ)•Support in scheduling and execution in internal audits plans and preparation.•Training for users on various systems (Agile, SAP, TW8) and processes.•Management of 3 QA interns.•Generate QMS reports.• Quality Plans and Interface Agreement Management.• Management Review(Metadata and presentation)Achievements:•ISO 13485: 2016 external audit by DQS part of the Baxter LHR team, as backroom coordinator. Zero non-conformities and a great result.•External audit management and part of Backroom (Certifying bodies, ETL, INNMETRO, corporate audits)•Controlled copies Log for the management of site.•Multiple process migrated to the Tijuana Site (Line Clearance, Visual Inspection, Good Documentation Practices, Change Control, Pest Control).•Quality System Dashboards (KPIs)

Tijuana, Baja California, México

Responsibilities:•Functional leader for the Quality Assurance within the documentation and Change Management (Everest PLM team)•Responsible for driving process harmonization within the assigned capabilities and differentiating only when there is added value for the business or challenge.•Testing strategy and test preparation, leadership role for delivering document/change management capabilities.Achievements:•Participate in change impact assessment workshops and owner of actions related with or how the business must adapt to utilize the capabilities to optimize value.

Tijuana Area, Mexico

•Development project for the stabilization and control of documents for corporate Hillrom.•Processing Quality Systems Document Changes on Agile and SAP.•Executed Periodic Review of Corporate Quality Systems Documents.•Executed of reports and Metrics (PowerBI and Excel).•Corporate documents clean up, finding owners Over 1K documents, and the correct update on Agile System.•Provide support and guidance to change originators through the Document Control Shared Service process.•Quality Matters CommittedAchievements:•Implementing a SharePoint to submit request for change orders.•Implementing a form for the Periodic Review Evaluation, a Work Instruction and collaboration with a PowerBI automatic reminder for documents impacted with Periodic Review.

Tijuana Area, Mexico

Responsibilities:•Assure quality requirements of new suppliers’ equipment or components, reviewing validation documents.•Maintain communication with sites around the world to comply with KPI´s for closure of suppliers change request.•Control of suppliers (Score Cards, Quarterly Review of Quality with suppliers.•Revision and approval of change orders assigned to supplier control ASL.•Define product/service segmentation level for components/suppliers.Achievements:•Migration of Global Approved List to AGILE MAP System.

Tijuana, Baja California, Mexico

Responsibilities:•Process, monitor and maintain changes to documents and materials within the QMS ensuring on time implementation (AGILE System). •Periodic Review Management•Train new indirect personnel on Agile PLM. •Filled out reports regarding daily change analyst activities. Daily support to local/external originators and approvers.•SAP Data load to ERP system for creation/change parts and components bill of materials.Achievements:•Diminished the return of change orders in 45%, increasing first pass yield, by implementing a change order checklist before submitting any change order.