Manuel Valdez Ruelas

• Collaborated with R&D to integrate quality considerations into early design stages, enhancing product durability and functionality.
• Trained and mentored junior engineers, providing guidance and direction.
• Implementation of innovation excellence program with all its methodologies such as DMR, FTQ, Flow acceleration and Zero Loss during de NPI projects.
• Collaboration in OQ/PQ activities.
• Collaboration during the process development activities.
• Project management.
• Collaboration with R&D, Manufacturing Engineers, production, DAE, Regulatory affairs during early stages to reduce as far as possible the gaps of the project.

I have been working as a manufacturing quality engineer in operating unit of CV/SHA, in the nitinol tubes, stent rings and stent graft processes within the manufacturing plant of Empalme, Mexico.

My experiencie in this position is related to:

• Problem solving tools (5 whys, A3)
• DMAIC methodology
• OQW applied to manufacturing processes.
• RTY improvements
• Root cause analysis
• Statistics (Descriptive and inferential)
• Design of experiments (DOE)
• Statistical process control (SPC)
• Agile Map: Creation and completion of change orders, collaboration and approval of change orders from different departments (QCH, DCH, PCH, RCH and EBR)
• Internal supplier events (ISE)
• TMVs (Attributes and variables destructive and non-destructive)
• CAPAs: I have experience as owner and collaborator.
• NCMRs: I have experience as owner and collaborator.
• Risk management: Creation and maintaining of PFMEAs and risk assessments for changes in manufacturing processes and non-conformities.
• FTQ coach level I: Implementation of the FTQ methodology and perform of the workshops.
• Process sustaining: Collaboration with engineering, production, maintenance, EHS and training to maintain/update/create quality standards and work instructions process steps for the manufacturing of components and products.
• Supervisor of direct quality inspectors personnel.
• Experience in DEKRA audits, M-CARE and CMMI.

During this period I used to give support to the SQE team in the next activities:

• Updating and maintaining the approved supplier list of the Empalme plant.
• Perform quality level impact assessment for new or existing suppliers
• Perform supplier segmentation activities.
• Follow up of change orders in agile MAP related update or create documents related to the suppliers.
• Collaborate during the phases of supplier master plan.
• Gemba walks to manufacturing areas to confirm all the supplies were registered and supplied by approved suppliers.