Maria Pena Email and Phone Number

-Lead the Design Assurance function, building a comprehensive Design Assurance system compliant to FDA requirements, by driving improvements into Design Control & Design Change procedures and policies and assisting in document writing -Support new product development and design changes ensuring product quality, reliability, speed to market, reduction of risk to users, and regulatory compliance.-Responsible for Risk Management, documentation, and assurance that Design and Manufacturing process changes are assessed for potential risks to customers or regulatory compliance. -Participate in Design Review and Design Change Meetings.-Provide design control assistance and mentorship to engineering team to implement an improved and robust Design Control system. -Develop tracking metrics of the design control process, risk management process and validation process.-Responsible for developing and maintaining a training and certification program for individuals specializing in Design Quality.-Manage human resources: provide direction to staff; approve staffing decisions; and develop the organization to ensure effectiveness.- Support internal and external audit, lead audit response strategy and ensure adequate corrective actions are implemented.

-Lead global quality operations and technical quality team for Surgical and Infection Prevention products.-Oversight of global manufacturing facilities in North/Central America and Asia. -Ensured high quality products and compliance to international quality standards while pursuing efficient operations.-Supervised six Quality Operations Managers and four Technical Quality Leaderss

-Lead a group of four technical quality leaders in the deployment of quality activities required to sustain and enhance existing products.-Facilitated the development and commercialization of surgical gowns, surgical drapes, face masks, respirators, sterilization products and gloves. -Supported product design changes and directed the implementation of design control and risk management strategies.-Provided technical leadership in the establishment of Design Control and Risk Management systems. Lead global implementation of ISO 14971-2019 (Risk Management).

• Actively participate in and facilitate the development of deliverables required for medical device product development and line extensions. • Actively participate in the development of product development plans, specifically components that focus on design reviews, quality plans, design transfer, and design verification/validation. • Direct all activities necessary for the project team to achieve design control deliverables, specifically deliverables related to product safety and performance.• Ensure new products meet customer requirements and specifications. • Lead and ensure compliance to all risk management requirements.• Partner within cross functional teams to determine root cause and mitigations of product issues• Implement Design of Experiments and Problem Analysis/Solving concepts in conjunction with R&E. • Actively participate in the development of statistical plans and rationale for design control activities/requirements.• Actively partner with the project teams to facilitate the incorporation of all quality system elements, root cause analysis, corrective action and continuous improvement principles throughout the entire product redesign. • Support and facilitate updates to the Design History File. • Incorporate the concepts of Lean Six Sigma to solve product /process nonconformance issues.

Cardiac Rhythm Management• - Brady Leads• Assess and approve validation documents • Craft traceability and training plans; review manufacturing instructions.• Support drug stability studies.• Created, implemented procedure to evaluate defects, nonconforming products in Prototype line.• Developed and implemented process monitoring plan and test methods for pull strength Acceptance Activities. • Provide cGMP training to managers, engineers, technicians and operators. • Assisted with all product development processes for design changes; conceptualization, analysis, component/systems design, manufacturing design, launch, and post-launch.• Assessed defect line reports, aided initiatives identifying root causes, ensuring corrective/preventive actions.• Supported external complaints investigations, safety risk assessments, corrective actions implementations.• Identified out-of-compliance events, drove Corrective and Preventive actions (CAPA).• Supported Lean Manufacturing and Six Sigma projects.• Supported internal audits; conducted investigations, helped audit of mfg areas, adherence to Quality System.

• Clients: Lilly, Merck, PfizerProvided Quality Assurance support during equipment/facilities validations.• Assisted with technical support at qualification protocol execution; evaluated validation documentation.• Assessed, produced discrepancy investigations during IQ execution for lab/HVAC systems at new plant. • Developed and coordinated BAS, HVAC and utilities validation activities and documentation.• Prepared project timelines; followed up on daily activities.• Revised, approved validation plans, protocols, discrepancy reports; organized data submitted for proposals.

• Developed batch records for new processes (solvent distribution systems; mechanical set-up; test runs, batch records).• Created SOPs for milling, solvent drum charge stations, detonation flame arrestor cleaning.• Performed start-up activities, including: defined interlocks, classified instruments, developed process change requests, identified and implement HAZOP (Hazard and Operability) recommendations