Quality Engineer Supplier

Paul Nepomuceno

Senior Quality/Validation Engineer - PLM - Regulatory

**********@*****.*** San Diego, 92014, USA 1-858-***-**** https://www.linkedin.com/in/paul-nepomuceno-

Summary

Dedicated Quality Engineer with over 10 years of experience in quality assurance, regulatory compliance and project management. Expertise includes leading audits, managing supplier quality processes, and implementing continuous improvement initiatives, Product Lifecycle Management (PLM). Skilled in managing product data, optimizing workflows, and ensuring cross-functional collaboration throughout the product lifecycle. overseeing design, development, and compliance, ensuring efficient product delivery and lifecycle optimization Work Experience

Quality Engineer - Validation - PLM Management, KONTRON, San Diego 01/2024 – 03/2025

IoT/Embedded Computing Technology (ECT) Digital Imaging, Image sensors. PCB, Optomechanical systems.

Lead audits, approve suppliers, monitor performance through Ai driven scorecards. Design Transfer Activities. Software Quality UAT testing. Create meta plan/Transformation program-strategic initiatives for PLM Product Lifecycle Management, End of Life Processes, Product recalls/ remediation. Enhance design, development, validation, and release.

Perform First Article Inspections GD&T

Oversee Calibration, ESD program, Test Equipment Validation, and Maintenance. Lead PPAP submissions DFMEA/PFMEA, Control Plan. Post Market Surveillance. Streamline API development, testing, and automation. GAMP5-CSV lifecycle. Supplier Quality Engineer / Lead Auditor / PLM, Stryker, San Diego 01/2023 – 01/2024

Mergers & Acquisitions

Lead audit teams in quality system audits at suppliers' manufacturing sites. Negotiate Supplier Quality Agreements and Change Agreements. Draft 21 CFR 806 Documents and reports for FDA Submission, oversee Post- Correction/Removal Verification, Customer Notification & Communication. Conduct Supplier assessments, effectiveness checks and update risk management files. Engage with regulators regarding submission requirements and guidelines including FDA, EU MDR

Participate in post-submission follow-up activities, FDA meetings and panel reviews. Design Transfer

UAT (User Acceptance Testing) for Product Lifecycle Management (PLM) Validation Engineer – Technical Operations, SCIEX, San Diego 12/2021 – 12/2022

Biopharma R&D, biologics, multiplex molecular diagnostics. Support commissioning, qualification, and test method validation. Coordinate decommissioning project for the commercial QC lab. Mass Spectrometry, PCR. Initiate chemistry manufacturing document updates for 510K regulatory submissions. Monitor supply chain quality and sterilization process for Capillary Cartridge Electrophoresis disposables. Validate batch records. High- Performance Liquid Chromatography (HPLC) systems: quality control, analysis, method development, validation, stability testing, dissolution testing, impurity profiling, and chiral separations. Technical writing, document review, author, and revise validation documents. Collaborate with Cross-functional teams

PLM/ QMS Manager, Philips Respironics, San Diego

11/2020 – 11/2021

PLM Teamcenter - Execute/ Manage Technical Documentation, Design Input/Output, Design Changes, DMR/DHF files. Implement Design Control and Risk Management, Supplier Regulatory Documentation. Risk Management: Hazard Analysis reports, (FMEA) Support Product Recall Remediation.

Regulatory Affairs-Premarket Regulatory Strategy 510(k) risk analysis, performance testing data, required by the FDA. Ensure documentation, device safety, effectiveness Oversee ERP Data Migration and consolidation of QMS Data in SAP from other sites. Draft 21 CFR 806 Documents and FDA Submissions, managing Post-Correction/Removal Verification.

Project Support Engineer / Assessment Director, AECOM, San Diego 10/2018 – 10/2020

Project Support Engineer (PSE) Integrated Project Team Development (IPTD) Program. Naval Consolidated Afloat tactical network. CANES consolidation and integration of shipboard legacy network programs to provide common computing environment. Certify compartment close out for renovated combat, habitat, medical and engineering spaces. Maintenance Repair. Work closely with teaming partners and stakeholders on plans to manage impact of a project, training, communication, risk/budget. Scope. Critical path to ensure on-time delivery of Milestones. Evaluate information regarding availability plans, financial resources, contracts, progress, Integrated Test Plans. Project QA Engineer, BAE SYSTEMS, San Diego

01/2013 – 10/2018

SME-QA for Fiber Optic, Optomechanical Equipment installation and validation for AEGIS ACB12 integrated combat readiness systems.

Coordinate contract review conference. Draft Project Charter. Planning, execution, critical path of project. Maintain Integrated Test Schedule. Certify compartment closeout. Ensure compliance with regulatory standards for medical berthing. Validate sterilization equipment, medical device integration with ships air, power, water, emergency generators, climate control as well as network connectivity with shipboard fiber optic network. Certify Critical Care Equipment CCE from Medical Device suppliers: cold/freeze room, dental equipment. Validation of IQ-OQ-PQ Test. Abbot i-Stat diagnostic systems. Validation Specialist - QA Final Test, CROSSFIBER, San Diego 04/2009 – 01/2013

Manufacturing and Prototype development of Optomechanical Devices, Fiber Optic Optical Switches, MEMS Micro Mirrors, Semiconductors, PCBA and bespoke collimated lenses. Coordinate field construction projects. Component Supplier for Class III Medical Devices used in Laser Guided Surgery, digital imaging, military, manufacturing equipment and data centers. IQ-OQ-PQ Validation. Engineering Change Order ECO procedures. Coordinate field construction projects (Kansas City Fiber Data Center), calibrate equipment. ERP Configuration/ Migration in SAP. Work with Product Development team to ensure regulatory requirements of Design Transfer activities are being met. Collect/ analyze data from reverse engineering activities to support SME’s for optimizing (DFM) Design Design verification.

Education / Certificates

Bachelor of Science, Industrial & Organizational Psychology, Mondriaan Aura College, Subic, Philippines

01/2002 – 01/2006

ISO13485:2016 Lead Auditor, Exemplar Global, Oriel STAT A MATRIX, San Diego 10/2023 – Present

Certificate# 202803

Electrocardiogram EKG Technician Anatomy & Physiology Certification, Cert# F3M5N3K2 - 2015, National Health Career Association, San Diego 03/2015 – 05/2015

ISO9001:2015 Internal Quality Systems Auditor, Certificate# 844****-****** (2016, Exemplar Global BSI Group America, San Diego

02/2016 – 03/2016

Fiber Optic Systems, FOTR Technician Supervisor/QA MIL-STD 2042C and MIL-STD 1678, – Kitco Shipboard Fiber Optic Systems Training and Certification Progr, San Diego, United States 01/2015 – 04/2015

Program/Project Management Competencies

Leadership – Guiding and motivating teams to achieve project goals. Communication – Ensuring clear, effective information flow among stakeholders. Risk Management – Identifying, assessing, and mitigating project risks. Time, budget, resource, quality Management Scheduling and prioritizing tasks to meet deadlines and Milestones.

Budgeting & Cost Control – Managing resources within financial constraints. Stakeholder Management – Engaging and addressing stakeholder needs. Project Charter - Critical Path

Scope Management

Quality Management – Ensuring deliverables meet required standards. QMS - Regulatory Competence

PLM /ERP Software

PLM /ERP Software

SAP, Perdoo, Trackwise, One PLM, EQMS, Tricentis Tosca, Microsoft Office excel, Word, Power Point, Microsoft Project, Microsoft Dynamics 365, Access, forms, SharePoint, Teams, Adobe, Agile, Cypress Waterfall, SAP, Epicor, Gherkin, Teamcenter PLM Propel, Scrum, PowerBI, Arbortext, Windchill Timeline, NMD (Navy Database Systems) Visio, Jira, Smartsheet, OracleTL, Maximo, Veeva EDMS, Salesforce, Procore8, ETQ QMS, Dataworks, MasterControl, IFS, Minitab, JMP (Statistical Applications, Gauge R&R), TRUcentrix, D365

(CAPA, SCAR, Audit Portal), HighGear Enterprise Workflow, Relyence (PFMEA + DFMEA) ISO13485:2016 Lead Auditor 21 CFR Part 820, 806 ISO 9001 Certified Auditor ISO14971:2019 ISO 10993 ISO 11137 IEC 62304, 62366 Medical Device Single Audit Program (MDSAP) IEC/EN 60601-1 EU MDR EudraLex Volume 4 Health Canada GMP AS9100 IPC-A-600 GAMP 5 GxP UKCA SaMD Software as a Medical Device Post Market Quality Buy America (BABA)

Kaizen 6S/7S Process Mapping Gap Analysis DFMEA/PFMEA Control Plan Root Cause Analysis 8D 5Whys LEAN 6 Sigma CAPA DMR Risk Management Files CSV GD&T

Ai Tools

Microsoft Power Bi, UiPath – Business, workflow and regulatory processes automation regulatory processes (life sciences)

Automation Anywhere – AI-driven RPA tool for streamlining workflow operations. Blue Prism – Intelligent automation, machine learning (ML) Workflow automation GAMP5- Computer System Validation CSV lifecycle

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