Pedro Mendez

Strong background and familiarity in implementing Quality Systems and Supplier Quality Systems improvements and relationship. Creating sound supplier metrics and inspection methodologies and maintaining a manufacturing environment in compliance with regulatory and ISO requirements.

Formula Plastics

Quality Director December 2020 – Current 

• Manage and direct the activities of the Quality Assurance Operational staff to ensure that Company operations remains in compliance with all supporting systems as per regulations. Also determine objectives, strategies, systems and procedures for the QA department. Establish a Risk based management system, in addition, monitor compliance and business need with appropriate departments to ensure operational objectives are met, both on the Technical Business Unit and Medical Business Unit.

Mammotome Tijuana BC.

Quality Assurance Manager July 2019 –March 2020

• Responsible for developing, implementing, maintaining and measuring the effectiveness of the quality system (inspection systems, policies, procedures, corrective actions and internal, audits) established to ensure compliance to all applicable regulations and standards (US CFR, ISO 13485, CMDR, MDD, JPAL, etc.)

Key Achievements

• Successful TUV re-certification  with cero findings
• Preparation of ¨war room¨ and audit checklist for external audits 
• Constructed air tunnel to minimize the lint/hair contamination on the white room. 
• Workload distribution of Quality engineers was implemented per area to improve service and on time response to manufacturing lines. 

Viant Medical (Formerly MedPlast) - Tijuana BC. 

Quality Assurance Manager Aug 2015 – June 2019

• Responsible for all aspects of the quality management and improvement process, on a medical manufacturing environment. 
• Manage customer relations and process improvements with the use of organizational, and leadership skills as well as a working knowledge of quality control measures and quality control programs in an ISO 13485 environment. 
• Ensure customer satisfaction with product quality by implementing sound corrective actions. 
• Responsible for internal audits and CAPA programs. 
• Mentor, develop, train and evaluate personnel, while maintaining a robust quality management system that meets all FDA and ISO 13485 requirements. 
• Established GEMBA walks to address real time correction thus reducing the amount of scrap in process.

Key Achievements: 

• Prepared the facility and team members by training on “External Audits”, thus successfully completed the ISO 13485:2016 transition.  . 
• Implemented the Quarterly management review
• Lead the expansion and validation of the cleanroom on time and effectively meeting the certification of the expansion. 
• Strengthen the current quality systems by revising documents to be in alignment with QSR/21 CFR 820 quality system regulations. 
• Established with sr. management the Key Performance Indicators to be tracked weekly and reviewed monthly.
• Reduced the CAPA backlog by 80% With Total Quality management and interdepartmental task teams
• Reduced the Complaint backlog by 95% With Total Quality management and interdepartmental task teams
• Implemented in house calibration (60%)
• Developed on site supplier monitoring and development (scorecard)

Bachelor degree in Biochemistry Engineering (1987) Instituto Tecnológico de Tijuana – Tijuana, BC

• Implementing ISO 9000 in a GMP Environment 
• Certified as Internal Auditor (BSI)
• Supplier Selection and Maintenance (U.S) 
• Systems, application and products SAP 
• ISO 13485:2016
• Medical Manufacturing validation processes
• ISO 14971 Risk Analysis for Medical devices
• Management and Leadership in Quality Management and Engineering (ASQC)