Over 8 years of experience in the medical device industry, able to understand current processes to identify opportunities for improvement. Throughout my career, I have worked in various quality roles, gaining experience in quality systems management, continuous improvement initiatives, and I have developed expertise in overseeing engineering projects as a supervisor. Communication skills and experience in the DMAIC methodology, along with the ability to lead cross-functional teams to enact organizational and departmental change for the benefit of the company. Comprehensive knowledge of CFR 820 and ISO 13485:2016, adept at critical analysis and developing comprehensive reports for QMS, SOP, supervision, and management.
Medtronic
View- Website:
- medtronic.com
- Employees:
- 97718
-
Supplier Quality Engineer SrMedtronicTijuana, B.C., Mx -
Engineering SupervisorMedtronic Sep 2023 - Present1. 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. -
Quality Assurance SpecialistHillrom Sep 2019 - Sep 2023Tijuana, Baja California, MexicoResponsibilities:•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) -
Quality Capability Lead (Everest’S Erp Modernization Project)Hillrom May 2021 - Dec 2022Tijuana, Baja California, MéxicoResponsibilities:•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. -
Qa SpecialistHillrom Aug 2019 - May 2021Tijuana 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. -
Supplier Quality EngineerMedtronic Jun 2018 - Sep 2019Tijuana Area, MexicoResponsibilities:•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. -
Config Assurance Admin, Quality Sys/EngMedtronic Jun 2016 - Jun 2018Tijuana, Baja California, MexicoResponsibilities:•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.
Angel Culebro Skills
Angel Culebro Education Details
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Industrial Engineering
Frequently Asked Questions about Angel Culebro
What company does Angel Culebro work for?
Angel Culebro works for Medtronic
What is Angel Culebro's role at the current company?
Angel Culebro's current role is Supplier Quality Engineer Sr.
What schools did Angel Culebro attend?
Angel Culebro attended Universidad Autonoma De Baja California.
What skills is Angel Culebro known for?
Angel Culebro has skills like Agile, Mini Tab, Agile Project Management, Sap Products, Team Workshops, Meeting Planning, Trackwise, Erp, Quality Assurance, Documentation Practices, Iso 9001, Medical Devices.
Who are Angel Culebro's colleagues?
Angel Culebro's colleagues are Eric Sauvignon, Mirza Baig, Markus Mangold, Technical Fellow, Jason Douglas, Javier Cano Zúñiga, Marlon Wilkinson, Wendy Griffin.
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Angel Culebro
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Angel Culebro
Solidaridad, Roo
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