Paul Nepomuceno

ad1z0z@r.postjobfree.com

https://www.linkedin.com/in/paul-nepomuceno-nebulacrush

1-858-***-****

Highly accomplished, innovative, dynamic, results driven professional with 10+ years of experience in Quality Management Systems, regulatory, compliance and Program/Project Management. A dynamic leader who executes with a high degree of integrity, excellency, efficiency, and passion.

QMS Competencies

Quality Management Systems ISO13485:2016 Lead Auditor 21 CFR Part 820 ISO 9001 Certified Auditor, ISO14971:2019 IEC 62304, 62366 EU MDR UKCA AS9100 GMP GDP IEC 62304 software validation Internal Audit Document Control Root Cause Analysis Change Control Design Control Statistics KPI’s Supplier Quality Quality Improvement Programs Calibration Technical Writing Business Developement LEAN 6 Sigma Problem-solving Process Improvement Process Mapping Gap Analysis Failure Mode and Effects Analysis (PFMEA) Regulatory Affairs 8D 5Whys Software Deployment and Implementation SaMD Software as a Medical Device Digital Software Design Quality Electronic Document Management Systems Leadership Product Lifecycle Management Kaizen ERP deployment and data migration. IQ OQ PQ Process Validation. GAMP 5 Good Automation Manufacturing Processes

Program/Project Management Competencies:

Lead the development of project charters, comprehensive planning, monitor-update schedule variances,

manage project budgets, communication plans, project review meetings, and time sensitive deliverables.

Execute readiness implementation and support plans that meet business milestone objectives and support

customer expectations using Lean Six Sigma Methods, PMBOK guidelines.

Articulate the projects impact on its stakeholders.

Work closely with teaming partners and stakeholders on plans to manage impact of a project, training, communication, risk/budget assessment using PMBOK PMO methods

(scope, management, tollgate, and risk & change management processes). Product Life Cycle Management

(PLM), implement automated workflow.

Identify, adjudicate and resolve issues that may delay project during execution phase, risk assessment and

management (identifying, communicating, mitigating, and escalating). Data Migration/Integration/Consolidation

Use data, process methods, metrics development to identify and validate readiness, execution efficiency and

process improvement opportunities.

Product Life Cycle Management, Risk File Management, Enterprise Content Management, collaborate cross-

functionally between departments to provide effective support.

Assess Cost of Quality (COQ) through statistical analyses to determine the responsibility for products or materials that do not meet required standards and specifications. Establish statistical requirements, sampling plans, and acceptable quality standards.

Risk based approach: assess and implement process improvement methods and procedures for inspecting, testing, and evaluating the precision, reliability, and accuracy of products, processes, regulatory, compliance and production equipment. Improve products and processes by applying continuous improvement and key lean manufacturing, production principles, and techniques to critical areas of production.

PLM /ERP Software: Trackwise, One PLM, Microsoft Office excel, Word, Power Point, Microsoft Project, Microsoft Dynamics 365, Access, forms, SharePoint, Teams, Adobe, Agile, Waterfall, SAP, Epicor, PLM Propel, Scrum, PowerBI, Arbortext, Windchill Timeline, NMD (Navy Database Systems) Visio, Jira, Smartsheet, OracleTL, Maximo, Veeva EDMS, Salesforce, Procore8, MasterControl, IFS.

P R O F E S S I O N A L W O R K E X P E R I E N C E

Stryker Supplier Quality / Project Engineer: GSQ Global Supplier Quality (July 2023 – Current) San Diego CA. – Hybrid (Remote/Onsite)

M&A Mergers and Acquisitions: Perform supplier assessments, support various supply chain-facing activities during the integration and onboarding phase. Interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management, and project teams. Drive Kaizen continuous improvement initiatives, Quality Improvement Programs QIP, provide technical support to enhance supplier quality. Collaborate with supplier and other cross-functional internal stakeholders to execute Product Lifecycle Management PLM. Oversee and manage design transfer and process transfer activities at Contract Manufacturer site. Design for Manufacturability (DFM), Design Simplification for efficient manufacturing. Serve as a liaison between Stryker Project team and critical suppliers. As lead auditor, lead audit team in comprehensive quality system audits at suppliers' manufacturing site (onsite and remote). SAP Audit Management to plan, perform, and track internal and external audits. Implement Risk control/ Management SiMD (Software in Medical Devices) IAW IEC 62304, 62366. (CAD), additive manufacturing (3D printing). Work with SME’s and Cross-functional teams to manage changes to digital design software throughout its lifecycle. Execute Supplier Quality Agreements and Change Control Agreements with supplier. Act as liaison between the Stryker and regulatory bodies. Communicate with regulators regarding submission requirements and guidelines: FDA, EU MDR, UKCA declaration of conformity. Post-Submission Follow-up: participate in FDA meetings, attend panel reviews, and advocate on behalf of Stryker to address any regulatory issues. Technical Writing, Update technical files, design documentation, risk files, clinical data, labeling. FDA requirements: SAP Supplier Relationship Management (SRM) to manage supplier qualification, evaluation, performance, change control and CAPA processes. Collaborate with cross-functional teams to evaluate proposed changes, material characterization, equipment, software, suppliers, or design specifications. Post-Change Evaluation: Monitoring and evaluating the effectiveness of implemented changes. Engage in Post Market Surveillance Activities.

Teledyne Instruments QA Engineer / Project Manager (Dec 2022 – May 2023) San Diego CA. – Hybrid (Remote/Onsite)

Participate in contract review to identify quality and regulatory requirements. Develop and initiate standards and methods for inspection, testing and evaluation for the Manufacturing of components for BD CareFusion Sensormedics IVD system, SaMD Software as a Medical Device, Digital Imaging and Omega Fiber Optic Connector product line. Write Technical Procedures for Design for Manufacturing Processes DFM: Wire Bonding, Rubber, Plastic, Injection Molding, 3d Printing, machining, surface treatments, and assembly techniques, geometry, tooling requirements, tolerance specifications, and ensuring compatibility with existing manufacturing capabilities. Process Improvement: Analyze process workflows, identify areas for improvement, and propose and implement process optimization measures to enhance efficiency, effectiveness, and quality. Analyze and report weekly: KPI’s, Cost of Quality / Price of Nonconformance PONC. Perform root cause analysis, implement corrective and preventive actions (CAPA) to prevent recurrence. Write, review, and maintain quality documentation, including procedures, work instructions, specifications, and reports. Use SAP to manage risk assessments, documenting risk mitigation measures, and monitoring risk-related activities. With SAP PLM, organizations can establish risk matrices and implement Change control. Reviewing change proposals. Supplier Quality Management: Collaborate with suppliers to establish and maintain strong quality standards and ensure the quality of incoming materials and components. Risk Assessment: Conduct risk assessments, FMEA. Quality Metrics and Reporting: Develop and implement quality metrics.

SCIEX Quality Engineer – Technical Operations (Oct 2022 – Dec 2022) San Diego CA. – Hybrid (Remote/Onsite)

Report on progress and roadblocks to the project. Develop and execute protocols. Coordinate decommissioning project for the commercial QC lab in San Diego. Contract Manufacturer for Pfizer. Execute Internal Audits and prepare company for supplier and external audits. Update engineering changes. Support commissioning, qualification and test method validation using Mass Spectrometer. Initiate chemistry manufacturing document updates for 510K regulatory submissions. Monitor supply chain quality and sterilization process for disposables. Validate batch records. Engage in technical writing, document review, author, and revise validation documents, change control and maintain other technical documentation for pharmaceutical chemistry manufacturing. Tracks and trends relevant documentation and data aper needs. Write/update manufacturing SOPs per GLP/cGMP guidelines. Participate and lead CAPA Projects, Root Cause Investigation and Analysis, corrective and preventative action. Documentation and Data Management: manage the documentation and data associated with cell and gene therapy analysis. Creating, reviewing, and organizing documents such as study protocols, clinical trial reports, manufacturing processes, and quality control data.

Philips Respironics Quality Engineer (Dec 2021 – Oct 2022) San Diego CA. -Remote / Hybrid

Execute Technical Documentation for Design Change, controlling DMR (Device Master Record) documents stored in Document Manager (EDMS). Deviation Process Documentation. Ensure integrity and maintenance of the QMS Quality Management System in manufacturing High Frequency Hospital Ventilators (Class 3 Medical Device) and sterilized consumables. In vitro diagnostics (IVDs), SaMD Software as a Medical Device. IQ OQ PQ Process Validation. Risk Management based approach IAW IEC 62304. risk control activities. Ensure that appropriate change control procedures are followed and that any modifications or updates are thoroughly evaluated for their impact on safety, effectiveness, and regulatory compliance. Provide quality assurance review for design control documents such as validation plans/reports and all associated documents. Implement Design Control. IT Validation, DCR Design Change Request with all applicable ECR Engineering Change Request. Facilitate Internal, external, customer and supplier Audits. Support Regulatory Affairs, Premarket Regulatory Strategy, Marketing Compliance, prepare 510(k) summary, device description, indications for use, risk analysis, performance testing data, and any additional documentation required by the FDA. Ensure documentation clearly presents the device's safety, effectiveness, and substantial equivalence to predicate devices. Develop risk management plans and implementing processes for monitoring and reporting adverse events or safety issues. Use SAP to manage design verification, validation, and review activities. Compliance with requirements for adverse event reporting, such as timely and accurate reporting to regulatory authorities FDA, EU MDR. Provide Post Market Surveillance Plan, MDR associated Quality review Data, Design History Files. Respond to Non-Conformance findings, CAPA’s, Product recalls.

AECOM Project Support Engineer / Assessment Director (Feb 2019 - Dec 2021) San Diego

Project Support Engineer (PSE) Integrated Project Team Development (IPTD) Program. Naval Consolidated Afloat Networks and Enterprise Services program tactical network. CANES consolidation and enhancement of shipboard legacy network programs to provide common computing environment for command control, intelligence and logistics. Assessment Director: execute Management Plan, the Change Proposal Process and Validation Process. Ensure the Visit Support Team (VST) performs logistics validation, data entry and data collection support functions necessary to properly execute and manage a Total Ship Readiness Assessment (TSRA) visit. Serve as liaison between US Naval Pacific Fleet Program Director and Southwest Regional Maintenance Center SWRMC Engineering Codes and Human Systems Integration engineers in the planning, development, testing, and validation. Certify compartment close out for renovated combat, habitat, medical and engineering spaces. Maintenance Repair and Decommissioning Program. Implement PMO lean 6 Sigma methods Critical path to ensure on-time delivery of Milestones. Evaluate information regarding availability plans, contracts, progress, Integrated Test Plans, test schedules, and test related documentation from the project team. Generate Engineering Service Request ESR with engineering SMEs to conduct assessments and preparing conditions found reports, Data Migration/Integration. Initiate Engineering Change Order ECO processes, Conduct Risk assessments and root cause investigation. Draft engineering work packages and write technical procedures included in biding contracts.

BAE SYSTEMS Project Engineer/ Supplier Quality Engineer (March 2014- Feb 2019) San Diego

SME for Fiber Optic installation and validation for AEGIS ACB12 Advanced Surface Missile System, Medical Equipment Readiness, Maintenance, Repair and Decommissioning Program for US Navy Ship building, repair, and Modernization. Contract review, Regulatory Affairs and FDA Compliance for medical berthing. Supplier installation repair and validate software implementation /integration with ships systems. Ensure all necessary documentation is created, maintained, and organized IAW IEC 62304, NATO standard AMedP-1.9 requirements for emergency medical supplies on board ships, Navy Standard DoDD 6000.12E, 21 CFR Part 820 and ISO13485:2016. Utilize SAP and NMD Navy Maintenance Data System to manage PLM, QMS, Design Control and update RMF Risk Management files. Update usability documentation. Update validation and test procedures, submit data and complaints to suppliers for post market surveillance activities, coordinate ECR engineering changes, risk control, risk management and Product Lifecycle Management. Evaluate and qualify suppliers. Facilitate CAPA activities. Manage Change Control: Review change proposals to ensure they are adequately documented, supported by appropriate rationale, have undergone appropriate approval processes and initiate contract changes. Develop robust change control policies, procedures, and work instructions. 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 suppliers: anesthesia systems, defibrillators, ventilators, pulse oximeters, suction apparatus and dental equipment. IQ, OQ, PQ. Test Method Validation. Diagnostic equipment: Abbot i-Stat diagnostic system, sphygmomanometers, ECG, non-invasive and non- invasive monitoring. Coordinate contract review conference Draft Project Charter: Planning contract review with all department heads, distribution of work, Project Execution: Deliverables, Integrated Schedule. Conduct QA surveillance and validate testing on Ships systems: propulsion, hydraulic, sea water, potable water piping, rotating motors, electrical, X-ray and NDT Testing welding of piping and structural repairs. System Safety MIL-STD-882E Hazard Analyses, MIL-STD-204, AS9100, 009-73 Integrated Ship-Board Fiber Optic testing. Insertion Loss, Power loss, OTDR, and Optical alignment.

CROSSFIBER Validation Specialist - QA Final Test Lead (April 2009 – March 2014) San Diego

Manufacturing and Prototype development of Fiber Optic Optical Switches, Semiconductors, and bespoke collimated lenses that are customized, calibrated and aligned for unique applications of each customer. Component Supplier for class 3 Medical Devices used in Laser Guided Surgery, digital imaging, military, manufacturing equipment and data centers. Clean room laboratory. Process control. Engineering Change Order ECO procedures. Provide input for CAPA and corrective action. Coordinate field construction projects (Kansas City Fiber Data Center), calibrate equipment. Work with Product Development team to ensure all aspects and regulatory requirements of Design Transfer activities are being met. Collect/ analyze data from reverse engineering activities to support SME’s for optimizing (DFM) Design for Manufacturability: Design verification (Test Methods, design outputs and design inputs). Design transfer scale up (set up for production: supplier evaluation, designing/planning manufacturing process, perform optical alignment, process validation, signal integrity test method validation, validation new manufacturing and testing equipment. QA evaluation analysis of large data sets. Implement risk management strategies: Design Failure Mode and Effects Analysis (DFMEA). Inspection: Insertion Loss meter OP815, return loss Optical Domain Reflectometer OTDR, Microscope, Height Gage, Bore Gage, Micrometer, Calipers, GD&T Geometric Dimensioning and Tolerancing methods IAW to ASME Y14. 5 and AS9100. Fiber Fusion Splicing, Micro-electromechanical system MEMS Mirror prep, stress testing, mapping integration. IQ OQ PQ. Maintain compliance to GMP, Implement Kaizen Methods, Root Cause Investigation. Write Technical Procedures. Maintain facility and calibrate equipment. Supplier Quality: Inspect incoming materials, certificate of analysis, and procedures. Design History Files (DHF) and Device Master Records (DMR). Process RMA returns.

Bachelor of Science in Industrial & Organizational Psychology Mondriaan Aura College 2002-2006

ISO13485:2016 Lead Auditor Certification Exemplar Global Oriel STAT A MATRIX

ISO9001:2015 Internal Quality Systems Auditor (TPECS) Exemplar Global BSI Group America Certificate# 844****-****** (2016)

FOTR Technician Supervisor/QA MIL-STD 2042C and MIL-STD 1678 – Kitco Shipboard Fiber Optic Systems Training and Certification Program – Sept 2015

CERT Community - Emergency Response Team Medical Team - Society of Networkers (Ham Radio License KJ6HMD) Relief Coordinator- Lingap “Aid to Humanity

E D U C A T I O N & P R O F E S S I O N A L D E V E L O P M E N T

V O L U N T E E R W O R K E X P E R I E N C E

Habitat for Humanities, San Diego CA

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