Mariana Oliveira MBA, QA-RA

·        Lead Quality and Regulatory Affairs for two FDA-regulated entities. ·        Designed and implemented corporate QMSR aligned with 21 CFR 210/211, 21 CFR ·        820, ISO 13485, and ISO 9001. ·        QA & batch record Management, final inspection, and disposition of finished goods. ·        Established and maintained Deviation, NCR, OOS, and CAPA systems, ensuring timely investigations and effective remediation. Ol ·        Led customer complaint handling, RMA, warranty, and credit processes within ERP, ensuring regulatory traceability and efficiency ·        Defined and executed internal, supplier, and process audits, supporting compliance readiness and continuous improvement. ·        Oversaw supplier quality strategy, qualification, performance monitoring, and corrective actions. ·        Managed Quality budget, staffing, training, and performance evaluation. ·        Supported company reorganization and scale-up while maintaining compliance and operational continuity.

ERP Project Manager, System Admin, Super User and user support Support Sales, Supply Chain, Operations and Service on ERP module implementation Engineering Change Management Leader [ECR, ECO processes and metrics] and Sustaining projects Operations Program Management - definition of manufacturing SOPs, Layouts, Optimization Projects aligning with Lean Manufacturing concepts Responsible for QMS implementation [KPI, Doc Control, Procedures & Internal standards] Customer Complaint Management [Ticketing System implementation and Continuous Improvement] Responsible for Internal scrap, NCR, CAR, PAR, problem solving, and warranty management HR support for development of People Management, Competence Management & Trainings Quality leader for New Product development

Reported to the Vice President, Product Engineering Responsible for Problem Solving, 8D, Customer complaints track system, and Continuous Improvement Supported Engineering development team on Quality Issues Change Management Coordinator, ECR, ECO process, system update (Axalant), and metrics. Defined Quality Procedures and Standards, according to corporate requirements (Northville) Implementation, management, and reported of company metrics and KPIs Supported HR in developing People Management

Led a team of 35 team members and reported to the Managing Director & President for South America Responsible for Quality Operations (Labs, Plant, Suppliers, Quality System & Customer relations) Responsible for Health, Safety and Environmental (HSE) organization and strategy Redefinition of the Quality System and new scope certification, achieved certification of ISO 9001 for Service department Budget planning and Management for QEHS investments Responsible for Supplier’s Quality Strategy definition Defined and performed QMS, HSEMS, Process and Product Audits

Led a team of about 20 team members and reported to the General Manager Responsible for the Quality EHS Systems Quality head of plant's start-up from the building to the complete ramp-up [Green field] Defined the Quality strategy and developed the hiring plan with HR Budget planning and management for Quality and EHS investments Co-responsible for supplier Quality strategy definition Defined and performed process and product audits internally and externally Team leader of “Right from Me” pillar – Sandvik Lean Manufacturing System Responsible for Customer Quality and Problem solving Responsible for Quality team performance evaluation

Led a multifunctional team of 15 people and reported directly to the BU Director (Altran) and functionally to the Head of Corporate Quality System (customer) Quality consultant- Fiat developing & implementing Corporate Quality System based on ISO/TS 16949 Implemented a management system, Training team, Develop process Map, & Business Process Deployments Process Audits & audited different processes in multiple locations as a representative of headquarters Lead multifunctional teams on engineering, manufacturing, HR & quality Responsible for Management Reviews with the CEO and direct staff

Led a team of 10 team members and reported to the Quality Manager Problem solving (internally and for Customers) using Six Sigma, 8D, 6M Quality tools Reviewed PFMEA & control plans Process & product audits Warranty analysis Developed a System to follow scrap indexes / Implement daily meeting to follow Quality indexes Prepared validation docs as VDA and PPAP Developed basic training for production for specific Customers: VW, Honda and GM Responsible for implementing QSB-GM

Led an indirect team of 15 members (APQP Teams) and reported to the Quality Director Follow-up APQP phases with logistics, engineering, Quality, purchasing, maintenance & Sales departments Developed and coordinated APQP documentation Reviewed PFMEA & control plans Process & product audits Analyzed specific Customer Requirements Followed production line audits and Customers Developed standard training for new production lines Contacted main Customers: Arvin Meritor (USA); GM Alisson (USA); FIAT (Brazil); IVECO (Brazil and Italy); GM (Brazil); PSA (Brazil and France); TRW (USA); VW (Brazil); Wabco (Brazil and Germany)

Reported to the Quality Manager and collaborated with different multifunctional teams Implementation and certification of Quality System based on TS16949 requirements KPI, procedures, and document creation and updates External Audit preparation and Internal Audit conduction for Quality Management System Trained employees on the new procedures / documents and requirements Responsible for 5S program implementation – WW standards Team member of new supplier’s development and qualification, including audits ISO 14001 & OHSAS 18001 implementations & Integration of the EHS Management System

Occupational Safety Engineering