Alexis Lopez Email & Phone Number

Houston, Tx, Us

- Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, overall design controls, design verification, design validation, investigations, CAPA data, etc. to assure product quality.- Assure conformance with regulations of the FDA and other international regulatory agencies and assist in providing responses to the FDA and other regulatory agencies with respect to medical device compliance.- Complete advanced design quality engineering projects for multiple sites in the USA, Europe and Mexico with peer input and guidance from design quality management.- Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.- Prepare, support and ensure the readiness for any internal and/or external audits and inspections (FDA, MDSAP & BSI).

Apodaca, Nuevo León, Mexico

- Ensure adequate Quality Engineering for Process Changes, Design Transfer Activities, Sustaining Projects, Remediation and New Product Introduction, to drive Quality Requirements and Risk Management across different sites (USA, Europe & Mexico).- Process Steward for all elements that Operations owns: Process Validation (pMVP, pFMEA, IQ, OQ, PQ), Acceptance Activities (Incoming Inspection Development), Control Plans, Device Master Records and Test Method Validations.- Partners with Operational Sites, Project Managers, AME Process and R&D to support Design Transfer Activities for NPIs and new technologies into production readiness.

Apodaca, Nuevo León, Mexico

- Leader of Incoming Inspection area, and indirectly supported Product Quality, NCM & Calibration technicians, interns and engineers.- Provide technical and engineering support to improve Product Quality KPIs (Internal & External DPU's, MRB, Scrap, etc.), through data collection, data analysis, experimentation and projects completion.- Responsible for driving the non-conforming material process and defects root cause investigation for multiple production lines, through coordination with Production, Manufacturing Engineers, Supplier Quality Engineers and Product Design Engineers. - In charge of Leading and supporting all Product Quality needs of multiple Business Units simultaneously and every day to day activities.

Apodaca, Nuevo León, Mexico

- Conduct root cause analysis on product quality issues, identify trends, and communicate with SQE's, Engineering and feeder plants for resolution of problems and or defects.- Experienced in CAPA creation/resolution and maintain records as specified by the quality system.- Leader of NCM Technicians and full owner of the NCR and MRB (Material Review Board) processes to reduce inventory, scrap and achieve goals stablished by management.- Create funnel and execute DPU and scrap reduction projects.

Apodaca, Nuevo León, Mexico

- Participate in early focus on manufacturability in NPI and/or Advanced Technology programs.- Plan the day to day execution and technical support for the introduction of processes for new product development and existing manufacturing. - Work with manufacturing leadership to identify and resolve manufacturing and quality problems related to methods, processes, tooling, equipment and product design.

Apodaca, Nuevo León, Mexico

- Experience and handling of eDHR system (Programming for different production lines, creating new electronic routes, Data Collection Plan’s and modifying Device History Records).- 100% eDHR Implementation on different production lines.

- Telemarketing, Sales, closing contracts, quoting services. - Monitoring and resolution of Customer Complaints.

Mexico

Telephone operator providing technical assistance. Developing skills for better customer management and support.

Master'S Degree, Business Administration - Quality & Productivity

Bachelor Of Engineering - Be, Mechanical & Administration Engineering