Debbie Ruiz, Msem, Cssbb Email & Phone Number

Miami, Fl, Us

Miami-Fort Lauderdale Area

• Plan activities and resource allocation to lead EU MDR approved product changes into production.• Develop communication and feedback channels between Manufacturing and Design sites.• Assess priorities to solve bottlenecks, identify risks and escalate critical activities that impact project status.• Apply best practices and lessons learned to streamline simultaneous product implementations.• Report project status, issues, and requirements to Management.

Miami/Fort Lauderdale Area

• Led process planning with manufacturing sites and served as liaison between remediation teams to ensure submission readiness.• Accelerated EUMDR State of the Art readiness by performing manufacturing technical assessments to comply with required standard operation procedures for CRHF and AFS processes.• Monitored project activities to support project status and deliver reporting data.• Provided feedback and guidance to sites when issues arose and followed-up with pending actions to meet submission deadlines.• Supported communication between internal and external EUMDR stakeholders.• Escalated to management the outcome of gap assessment to facilitate key business decisions between remediation/phase-out options.

Miami/Fort Lauderdale Area

• Led actions and activities to support FDA 483 response.• Aligned Risk Analysis Report and dFMEA with latest Issue Impact Assessments.• Established metric (KPI) and managed Risk Management File to reduce aging tasks.• Updated and released Production and Process Control Plans to Corporate requirements.

Miami/Fort Lauderdale Area

• Participated in the implementation of RBQM as a business strategy to facilitate Continuous Improvement.• Performed Gap Assessment as part of a Risk Based Quality Management remediation project to align Production Process Controls (DWG’s, Process Maps, dFMEA, pFMEA, Inspection Procedures and Control Plans) and fulfill Regulatory Compliance• Performed technical evaluation of legacy test method validations and re-executed to new standards required to ensure processes reliability and repeatability.• Wrote TMV protocols and reports, conducted and supervised testing and performed statistical analysis with Minitab• Assisted in investigations and non-conformance reports as well as conducted research to identify the root cause.

Quito, Ecuador

• Managed projects and new process developments within the assembly line for MAZDA in collaboration with the Supply Chain, Manufacturing, Quality and Engineering departments.• Benchmarked and implemented Lean Manufacturing tools according to plant necessities.• Measured, monitored and reported effectiveness solutions through key performance indicators (KPIs)• Performed follow-up audits to ensure completion of action plans for 2nd and 3rd party audits.• Instituted a visual factory program to ensure production and quality indicators were accessible to everyone.• Managed a continuous improvement reward program and increased plant participation form 25% to 100%.• Enforced compliance of corporate procedures in all levels of the company.

Quito, Ecuador

• Taught Production Fundamentals course to first year students.

Quito, Ecuador

• Monitored and lead local auto-parts (seats, fuel tanks, rims, etc.) developments from reverse engineering practices.• Conducted standard operations procedures, pilots, gathered feedback and integrated improvements promoting best practices.• Complied with customer’s engineering requirements (KIA, GM, and MAZDA) and met ISO TS 16949:2008, Six Sigma & Core Tools (MSA, FMEA, PPAP, APQP, SPC) standards along document control.• Improved costs, takt time and assembly processes.• Led and planned multidisciplinary team meetings for process development and problem solving.

Quito, Ecuador

• Led ISO 9001: 2008 internal audits and oversaw the Quality Management System.• Reviewed, improved and updated process mapping (flow charts) jointly with process owners.• Implemented BASC (Business Alliance for Secure Commerce) Management System.• Internal ISO 9001:2008 Auditor.

Lexington, Kentucky, Estados Unidos

• Designed and reviewed digital welding jig models and apply kinematics using I-grip.• Inspected safety specs required by TOYOTA,GM and SUBARU prior to manufacturing.• Designed and verified installation drawings for equipment before shipping.• Procured parts and components for assembly.

Master’S Degree, Engineering Management, Entreprenuership, 3.4

Bachelor Of Applied Science (B.A.Sc.), Technology And Industrial Arts

Activities and Societies: International Students Club, HSA Hispanic Students Asociation, Tec Club