SUMMARY:

• Highly accomplished, innovative, dynamic, results - driven professional with 8+ years of experience in Quality Management
• Systems and Program/Project Management. A dynamic leader who executes with a high degree of integrity, excellency, accuracy, efficiency, and passion.
• Quality Management Systems | ISO 9001 Certified Auditor, ISO 13485 FDA, ISO 17025, ISO19011 |QSR |21 CFR Part 820 (Medical Devices) |GMP|cGxP|Internal Audit | Document Control | Change Control |Root Cause Analysis |Design Control | Statistics | KPI’s | Safety | Math Skills | Supplier Quality | Quality Control |Calibration| Technical Writing | People Management | Customer Service |Time Management | Business Development | Problem-solving | Process Improvement | Process Mapping | Gap Analysis | Work Ethic | Communication | Confidential ce | Adaptability | Strategic Thinking | Decision Making | Failure Mode and Effects Analysis (FMEA)| Regulatory Affairs | Software Deployment and Implementation| Electronic Document Management Systems| Leadership
• 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 project's impact to its stakeholders. Work closely with teaming partners and stakeholders on plans to manage impact of a project,, communication, risk/budget assessment using PMO methods (scope, management, tollgate, and risk & change management processes). Product Life Cycle Management (PLM), implement automated workflow.
• Supply Chain Logistics management, Integrated Planning Scheduling and Coupa Procurement
• Execute readiness implementation and support plans that meet business milestone objectives and support customer expectations, Identify, and monitor key indicators to monitor critical path and ensure project success, align resources and operations with business objectives.
• Identify, adjudicate and resolve issues that my delay project during execution phase, risk assessment and management (identifying, communicating, mitigating, and escalating).
• Use data, process methods and dynamic thinking to identify and validate readiness, execution efficiency and process improvement opportunities. Creating and writing technical work instructions
• Product Life Cycle Management, Enterprise Content Management, collaborate cross-functionally between departments to provide effective support

TECHNICAL SKILLS:

Quality Control QC Tools: Flow Chart, Pareto Chart, Cause and effect chart Ishikawa Fish Bone Diagram, Scatter Gram, Histogram, Control Chart. Gant Charts

Gap Analysis tools: SWOT Analysis, McKinsey 7s Model, Fishbone Diagram, Nadler-Tushman s Congruence Model, PERT Technique

PLM /ERP Software: Microsoft Office excel, Word, Power Point, Microsoft Project, Access, forms, SharePoint, Teams, Adobe, Agile, SAP, Propel, Scrum, PowerBI, Timeline, NMD (Navy Database Systems) Visio, Smartsheet, Salesforce, Procore.

PROFESSIONAL EXPERIENCE:

Confidential, San Diego CA

Quality Management Systems Project Manager

Responsibilities:

• Validation of internal control processes are compliant and operating effectively, compliant to ISO9001 and ISO13485 FDA, ISO17025, 21 CFR part 11, 210, 211EU Regulations. Liaison and Quality representative for the project team. Coordinate and facilitate Internal and external, GMP Audits, Support Regulatory Affairs, Premarket Regulatory Strategy, Marketing Compliance and 501K Submissions. Respond to FDA, BSI, and Auditors. Respond to customer complaints. Ensure quality Plans are consistent with quality objectives and requirements. Update quality plan. Generate Monthly Quality Review Board Slide. Provide Post Market Surveillance MDR associated Quality review Data. Maintain archival of data analysis records (DHF Design History Files). Coordinate the analysis of complaint data and prepare monthly complaint trend reports. Respond to Non-Conformance. NCMR: Non-Conforming Material Report, NCER: Equipment Report, NCPR: Process Report. Risk Assessment. Evaluate and report severity, frequency, and trend.
• Escalate to CAPA. Consult with SME’s, Provide input to CAPA team. Support Root Cause Analysis. Manage outstanding CAPAs’. Class 3 Medical Device. Product Life Cycle Management (PLM) system implementation/integration Electronic Document Management, Engineering Change Order ECO procedures, Change Control, Recurrence Control: update quality plans, procedures, design, and . Maintain integrity of GMP standards. Gap Assessments. Validation of Design History Records, Device Master Records, batch records, Testing, Calibration of equipment, Inspections, Surveillance, Audits, and documentation ensuring consistency and compliance of manufacturing activities. Electronic Document Management, Conduct monthly Quality Review Board meeting with Project Team. Generate and maintain a visual representation of remaining work and trends (Burndown). Develop and maintain a tracker matrix that tracks changes, variances, activities, dates, deliverables, and relevant information pertaining to the project. Implement continuous improvement. Meeting customer and regulatory requirements.

Confidential, San Diego

Project Support Engineer/ Assessment Director

Responsibilities:

• Serve as liaison between Confidential Pacific Fleet Program Director and Southwest Regional Maintenance Center SWRMC Engineering Codes. Project Management lean Sigma methods ensuring on-time delivery of Milestones. Evaluate information regarding availability plans, contracts, progress, Integrated Test Plans, Integrated Test Schedules, and other test related documentation from the project manager. Generate Engineering Service Request with engineering subject matter experts to conduct assessments and preparing conditions found reports. Initiate Engineering Change Order ECO processes, Conduct Risk assessments. Draft engineering work packages and technical procedures included in biding contracts. Verify compliance with Quality Management systems ISO9001 and engineering principles, integration approaches, testing requirements, budget, and scope. Conduct risk assessments and post project analysis IAW Confidential Standard Items. Quality Management Systems -Assessment Director. Technical Authority.

Confidential, San Diego

Project Manager/Internal Auditor

Responsibilities:

• Project Management lean Sigma methods ensuring on time delivery of project IAW Confidential Standard Items, Confidential Technical Specifications. Manage and supervise QA Team of 5 (2 QA Inspectors, 1 Document Control Specialist and 2 Test Coordinators) assign task, direct testing, delegate workflow and manage time keeping. Work directly with auditing bodies, business stakeholders, vendors, subcontractors and third parties to ensure execution of deliverables and create a compelling, relevant project vision using web metrics, customer insights. Lead the appropriate teams to refine, prioritize and manage requirements.
• Define and resolve dependencies, issues and risks and identify impacted areas through team collaboration. Develop, maintain, and improve Quality Management Systems (QMS). Implemented developed Integration initiatives to ensure efficiency compliancy to Conduct Audits on Objective Quality Evidence submitted by Subcontractors while maintaining document control. Subject matter expert in Fiber Optics. Pre/post- install photon light verification test as well as insertion-return loss test, attenuation, fiber trunk and supporting system topology fiber plant testing, OTDR (optical time domain reflectometer) trouble shoot, interpret, approve submitted data and report in-process results. Implement OHSA safety Procedures.

Confidential, San Diego

Validation Engineer - QA Final Test

Responsibilities:

• Manufacturing and Prototype development of Optical Switches and lasers applied in Biotech and Medical Devices, Military / Aerospace, manufacturing equipment and data centers. Quality Assurance of Signal Integrity. Clean room laboratory. Process control. Engineering Change Order ECO procedures. Maintain compliance to GMP, ISO9001 QMS, 13485 FDA, 17025 Lab, ISO14971 Risk Management, ANSI 14.5 Geometric Tolerance.
• Support Internal and External Audits. Process Validation. Maintain facility and calibrate equipment with PM and calibration Schedule. Supplier Quality: Check materials and supplies, validity of batch records and procedures. Design History Files (DHF) and Device Master Records (DMR). Process RMA returns. Respond to Non-Conformance. NCMR: Non-Conforming Material Report, NCER: Non-Conforming Equipment Report, NCPR: Non-Conforming Process Report. Provide input for Root Cause Analysis. FMEA Execute Failure mode effects analysis. Systems Integration of Fiber Optic Collimators with 3D MEMS micro-mirrors.
• Fiber prep, Fiber Management, Fusion Arch Splicing, Silicon wafer quality inspection, Innervation of fibers into silicon wafers using microscope camera, JDS meter, Optical Time Domain testing. UV Omni Cure treatment, oven treatment. Thermoforming, Fiber Array Polishing, Fiber Core inspection, alignment micron spec. CAD Solid works, Precision tools, Mechanical inspections, Geometric Dimension and tolerance, Calibration of Injection Modules. Soldering of Boards, wires and Cable Assembly, Building Power Supplies. Process improvement, providing input to Optics Engineers and assist with Technical Drawings and Schematics. Design and Fabrication of prototype chassis units, electronic circuit Board Testing, leakage, curvature, conductance threshold, technical writing and developing operating procedures.