213-***-****

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CHANTEL HILL ENGINEER/PROGRAM MANAGER (QUALITY)

PROFILE

While being a multi-dimensional hands-on business professional that provides leadership, vision, creativity and business acumen in driving and managing business growth. I am also skilled in relationship building, Quality Engineering, Project Management, Liaison Engineering, & working in manufacturing environments. I am accomplished in planning, scheduling & executing projects from concepts through production, with strong troubleshooting and problem –resolution skills. Also, highly organized and detailed oriented. I demonstrate broad strengths

EXPERIENCE

Stryker Sr. Supplier Quality Engineer/ Compliance - IAZ CDR Regulatory Consultant (Med Device)

EU MDR Compliance auditing through all supplier documentation including a request for supplier PFMEA.

EU MDR Medical Device Regulation 2017/745. Routers & Component Level data, Review of all drawings Validations, SDS, Process Flows & & Generic PFMEA; gathering data for contact material spreadsheets.

This included all instruments, implants & OEM supplier SPC, Process Control & Root Cause gain a high level of organizational skills and knowledge of regulatory requirements, standards and regulations to manage and inspect audits/FDA requirements and supplier data. Works close with Project Management & collaborate with strategic sourcing, auditing and development groups to understand capabilities and competencies of suppliers to meet our requirements and continually meet and adapt to a product quality and regulatory requirements. . Hazardous Substance, Procedure & Process documenting. Daily interaction with suppliers. Liaison between Engineers, PM’s & Biologist. Lead weekly meetings to ensure scope was being followed within peer groups.

Company Name Un Disclosed Quality Manager Consultant

Adhered to CAPA with customers such as Caterpillar Lafayette, Decatur, & Aurora. PPAP, ISIR with Customers such as LME Liebherr, BAE & BWXT including structures for Northrop Grumman. Oversee NCMR process, QMS. Received, review reports for approval from CMM machine for customer dimension approval. Internal Audit performed, update of Purchasing Dept for PO contracting. Work close with Engineering, Plant Manager & Program Manager on conformance of CNC machined components and assemblies for military and mining commercial applications. Specialist in Large Metals Fabrication with Special Processes including Welding. Develop metrics and performance indicators. Continue to improve QMS system. Oversee CAPA, Lead Management Review, customer onsite audits, submit PPAP including PSW, Control Plans & APQP. Represent the company during company visits, assist in cost reduction and daily activities. Adherence to all customer policies, in support of the company’ mission, vision values and goals in the performance of daily activities. Maintain a positive relationship with all levels of the organization. Ensure all procedures and work instructions are communicated properly. Maintain knowledge of control techniques. Comply with internal OSHA required for safety procedures in the performance and hold all directs reports accountable for enforcement. Manage and drive corrective action process. Ensured all Government documentation and requirements are adhered. Direct Quality within Special Process. Conform to Suppliers requirements to maintain customer performance. Handle customer complaints assist in writing communication travelers & disposition of suspect material whether internal or external. Provide approval for temporary deviations and other related authorizations. Champion problem solving, FTQ, and CAR continuous improvement efforts. Oversee ISO 9001:2015 Audit to gain compliance for continued contracts. Visit Suppliers Oversee onsite customer audits. Resolve customer complaints.

The Synergistic Group 2017- 2019 VP Global Quality Regulatory Compliance Consultant -

Promote Quality awareness and continuous improvement though strong relationships with site and business unit customers. Developed and strengthen global Quality Systems. Implemented enterprise Quality policies and procedures across the network. Aligned internal processes and metrics to create a high level of product quality and consistency. Determined the appropriate infrastructure and resources required to achieve business objectives. Provide leadership and strategic direction to Quality Units across the network. Ensured the proper interface of the Quality function to product development, manufacturing, marketing and other cross-functional partners as required. Collaborated across sites and functions to ensure that quality standards and GMP compliance are met and maintained. Developed and monitor appropriate metrics to track quality and process improvement. Met with Stakeholders regarding Risk Management and Process Control adherence. Upheld ITAR status. Developed and implement the required organizational processes and competencies to ensure that Fulfilled Exec. Project Manager role for a distinct set of clients by serving as primary client contact, translating client needs into a defined scope of work, and working with staff to delegate and effectively complete client deliverables. Implemented processes and procedures and conduct analyses to sustain and improve the Quality Management Systems of clients. Examples include risk planning, analysis, design controls, verification and validation, and inspection methods and procedures. Define production and inspection methods, monitoring performance, and handling nonconformances. Conducted post-market activities including complaints handling, MDR evaluations, and CAPA assessments. Support Top Management and consulting group in the development and implementation of client objectives. Perform engineering research, statistical analysis, write technical protocols / reports using relevant standards and data. Work with suppliers, laboratories, clients, and other group members to assist with implementation and effectiveness of client deliverables. Worked with Quality Specialists to generate and release Engineering Change Notices and implement document controls. Review prints, data, procedures, and test protocols / reports for accuracy and technical application of standards (ISO, AAMI, ASTM, and IEC) for electromechanical systems. Provide analysis for ongoing continuous improvement. Worked within Medical Device for the Project Management of Remediation Plan.

Trane / Ingersoll Rand 10/2013-04/2018 Supplier Quality Engineer (HVAC) Contract Clarksville, Tennessee

Provided supplier with technical oversight and expertise in areas such as Process Development, PFMEA, Measurement Systems, Control Plans and Error Proofing. Conducted technical drawing review with supplier to ensure supplier understands all the requirements on the drawings. Proficient in contemporary QC and QA tools such as QMS, APQP, SPC, and PPAP. Working knowledge of tool design, Geometric Dimension and Tolerance and dimensional metrology. Cognizant of drawing interpretation and injection molding. Conducted component risk assessment that defines PPAP level and Create PSW based upon risk assessment. Knowledge of Primavera w/Gantt Chart. Monitored supplier’s performance and adherence to the Global Supplier Quality Manual travel 20% of time, to onsite customer base.

Siemens 02/2012-08/2013 Sr. Project Manager/Quality Compliance Medical Device & Aerospace Contract – Pomona, CA

Organize material and complete Quality Research for AFS, GL, Fixed Assets and ERCA Requirements. R& D Agile Teams. Lead and manage cross-functional, cross site teams representing all Product Development Life cycle phases including project planning, scheduling, tracking coordinating and monitoring activities. Create and manage project scope, schedule and budget. Assure that all product success meets deliverables, which will include performance, cost, schedule, and revenue. Identified the needed decision and drove the decision-making process. Schedule and lead meeting to coordinate inter-departmental project activities; including those necessary to resolve project issues. Commitment to meeting the expectations of internal and external customers. Interface with Senior Functional Managers and Business unit leadership as needed for resource management and performance reviews. Manage project communications to all stakeholders, including meeting minutes, monthly updates, communications meetings, and phase reviewed. Identified and implements process improvements between department on a day to day basis and maintain liaison with all members of the project team meetings. Responsible for continuous improvement of the product development process to streamline time and market.

Denso 06/2011- 12/2011 Quality Engineer (Automotive) Contract - Tennessee

Control Process, of components, assembly. There was understanding of PPAP in which Quality supported design and process change approvals. Understanding of ECOs; Liaison to communicate with customer, manufacturing & design team for resolution of quality issues. Warranty improvement for commodities and Reports for both written and oral internal and external customers. were administered. There was team collaboration for quality improvement & Special request. Submittal of FAI. Worked as a close Liaison with Engineering as a Technical Resource due to GD&T. Perform supplier on site audits to check capability, processes, control plan etc. Perform new supplier PPAP and early stage control activities identify high risk and critical to quality suppliers; establish quality improvements activities compile supplier failures data from incoming inspection, in process, customer and field returns to maintain supplier quality performance trends and periodic reports track parts and corrective action.

NuVasive 02/2010 – 02/2011 Sr. Supplier Quality Engineer (Medical Devices) Contract/Consultant - San Diego, CA

Worked proactively to manage and drive continuous improvements in total quality systems through direct partnership with Operations, Maintenance and CI to instill quality ownership, knowledge and awareness in all aspects of making, packing and shipping our products. Carried out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities included interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems Represented Quality Engineering in third party audits (FDA, Notified Bodies, etc.). Supported the analysis and presentation of information to executive management concerning measures of product and service quality, supplier performance, manufacturing problems, and design issues as identified through various quality systems program elements.

Performed duties in compliance with applicable regulations and standards such as FDA Quality System Regulation 21 CFR 820, 803, 1270 and 1271, ISO 13485, and the European Medical Device Directive. Reviewed technical publications, articles, and abstracts to develop applicable skills and to stay abreast of quality, regulatory, compliance, and technical developments in the industry. Attended such conferences, seminars, professional meetings, and other public forums as are relevant to the interests of NuVasive. Supported additional assignments of the Q.E. Department, as required. Supported development of adequate inspection criteria. Evaluate product changes for qualification and validation requirements and assist in change implementations. Ensured proper statistical methods are applied to testing, validation, sampling, inspection, etc. Supported transfer of design to contract manufacturer, including establishment of quality agreements, development of adequate inspection criteria, and coordination of validation testing as required. Evaluate product changes for qualification and validation requirements and assist in change implementations. Assisted in the identification and qualification of equipment required to perform inspection. Developed new quality initiatives, participate in quality system development, procedure writing and review, and improve quality and reliability of products. Reviewed and approve new documents and product changes for compliance by serving on the change and design control boards. Coordinate and manage risk management activities. Performed in-depth, fact-based assessments of manufacturing operations to identify losses and gaps in program, process or procedure as a part of the Zero Loss Journey. I also possess IMD & close tolerance injection molding knowledge. Provided technical expertise to the Manufacturing Operation by identifying program and process variation and implementing corrective and preventative actions via proven practices or innovative technology. Actively established and/or improve standards for manufacturing practices and methods that produced uniform products in compliance with company specifications and all government regulations. Used as a training and development position. Leader in providing statistical information and managing issues in weight control, product composition, product attributes, consumer complaints and other areas as required. Supported Integrated Lean Six Sigma (IL6S) loss elimination processes as well as product and process improvements. Led ISO recertification effort, which was granted on first attempt. Conducted process mapping and time/capability studies to improve throughput by 26%, eliminate bottlenecks and ensure adherence to customer specifications. Lowered product returns by 12%, saving $150K per year. Cut number of complaints in half by accelerating response times to customer inquiries.

GE 09/2008-10/2009 Sr. Project Quality Engineer (Aerospace Turbine Engines) Contract - Boston, MA

Perform and submit FAI reports and procedures & approval. Write and develop new procedures, Establishing and maintaining information systems along with creating reports with root cause analysis. Provision of Project Planning & Scheduling. Sample Production Parts. Lead corrective and preventive action initiatives, Knowledge of Non-Destructive Testing, R& D, auditing procedures, performance of reliability on weaponry systems. Ensure ISO compliance by maintaining/creating processes and documentation. SPC on applicable manufacturing/repair operations to determine process stability and verify proper implementation of process control. Tracked all outstanding corrective actions and partner with appropriate remediation team to ensure actions are completed on schedule. Work with information controls and how they apply to the standard. Apply project management expertise across multiple simultaneous corrective actions. Partner on high and critical priority corrective actions based upon risks and exposure to the environment. Partner with Security/Compliance/Technical Support experts to ensure effective corrective action solutions/plans are logged and updated. Partner with remediation teams (DTSS Delivery, Business Unit Delivery Technical activities to ensure maximum quality and effectiveness. Knowledge of Critical Chain Project Management (CCPM), Event Chain, Supervised and guided quality managers and departments to establish quality standards as per industry and market requirement. Understanding Quality Scope, Standards, Define & Estimate Activities.

Lockheed Martin 03/2008-08/2008 Sr. Project Engineer ( Aerospace/Weaponry ) Contract – Boston-MA

Developed new or updated existing technical documentation IAW customer approved Style Guides. Developed TMs in baselines, Hell Fire Project. Book plan development to identify engineering sources data with weapons specs. Worked closely with Engineers, documentation & clearance writings. (Priority Government Driven Limited of what can be discussed within this scope)

Env. Services Inc. 01/2007-03/2008 Sr. Quality Engineer/Internal Auditor Contract - San Antonio, TX

Quality Engineering and Taking charge of Quality Audits for New Product Certification with UL & NSF. Grant Writing for Company, with Energy Department. Six Sigma & Kaizen Events. Completion of Lean Six Sigma with Villanova. New Product Development, Creating Quality Standards, KANBAN, Takt Time, Pareto Charts -Create and Developed Quality Manual. FDA Quality System Regulation 21 CFR 820, 803, 1270 and 1271. Inspected finished products, raw materials, supplies, equipment, personnel, and facilities for adherence to quality specifications, current Good Manufacturing Practices, and sanitation. Communicated effectively and thoroughly to management and peers any test results or inspection findings outside of specifications. Managed product holds and release system. Identified non-conformances in quality or practices and take or recommend appropriate corrective action within scope of knowledge. Operated, monitor, and control water process systems including Ultra-violet lights. Reverse Osmosis filtration process, distillation process, sub-micron filtration process, pumps, valves, and instrumentation. Read gauges, meters, chart recorders, and controller readouts and record data. I kept accurate, complete, and legible records, for traceability purpose. Properly amended, identify, and file records. Safely handled chemicals, biological agents, and waste, with documentation provided. Potentially including hazardous materials. Read, understand, and maintain material safety data sheets. Conducted housekeeping and general labor duties as assigned. Volunteered with Florida Solar Center Scientist on the Building America partnership funded by the Department of Energy. Monitor the implementation of the approved site QC Plan -Coordinated with quality inspections with all the site sub contractors and vendors coordinate all non destructive testing on site-Coordinated with the customers representative on all quality matters--Coordinated all receipt inspections--Distributed relevant QA/QC documentation to site subcontractors--Implemented and conducted training program.

Keathley Aerospace 10/2003-12/2007 Sr. R&D Project Manager Contract – Mobile, AL

Manage large-scale client programs focused on business growth, technology advancement and process improvement across value-chain activities such as logistics, operations, sales and service. Team Leadership: Built and managed talented teams of business analysts, programmers, developers and other specialists. Supervised up to 10 personnel per engagement, coordinating between in-house and client teams and keeping stakeholders informed of progress and milestones. Process Mapping: Saved Engineering Consulting company $2.3M annually after leading end-to-end mapping of procurement process and training end users on new Quality Control System. * Supply Chain: Worked with global Large scale manufacturer to resolve quality and packaging issues negatively impacting the bottom line. Lowered defect rate by 18% and improved manufacturing flow by 15%. * Business Integration: Led integration of systems, processes and workflows for two merging biomedical companies. Paved the way for accelerated growth, enabling profit gains 16% above target within 6 months. *KPI Dashboards: Built KPI dashboards that improved the accuracy, transparency and compliance of financial reporting and planning for numerous client businesses. *Logistics: Guided customization and implementation of fleet-tracking software for natural foods company. Improved outbound logistics efficiency by 25% and on-time delivery performance by 19%. *Managed the project of IT Infrastructure: Evaluated and streamlined core IT system. Retired obsolete apps, established scalable platforms supporting business growth and strengthened information security. * Update Internal Specifications to meet customer requirements. Improved BMC, SMC techniques in order to produce greater amount of parts than before by eliminating scraps and introducing new compounding and pressing techniques. NADCAP Audits Special Processes/AS9100-Oversee Chemical Processes exp. NDT, Welding, CNC, Testing, Hardness and Conductivity Lab, Paint-On Management Quality Team, work closely with Sr. Quality Engineer and Sr. Responsible for Audit Criteria per AS9100 requirements and DMV audits determination with given special process area -Work close with Manufacturing Process & Extremely familiar with MIL-Standards 1500-1599 Safety Training for Professionals, Managing Safety Performance; Courses on Fire Safety and Loss Prevention; Industrial accident investigation technique; American Red Cross Training; job Safety Analysis Training; Behavioral Safety. Lead multi-disciplinary projects throughout lifecycle. Accurately forecasting project cost, cash & resource demands. Build and maintain excellent internal and external customer relationships. Create, maintain and communicate project plans and technical documents. Identify and manage project related risks to minimize their impact. Contribute ideas towards continuous improvement of program strategy. Ensured that subcontract activities are managed effectively ; Ensure adherence to company policies and procedures. Administer Risk Reduction Engineering

EDUCATION

Harvard University- Physics/Engineering Physics Minor Chemistry

Villanova University -Liberal Arts/Project Management

Lean Six Sigma-

SKILLS & INTERESTS

Finite Element Analysis * FDA- CFR / ISO13485/ GMP/ AS9100 * TS16949-UL-NADCAP-SCAR-QMS-6W2H-HACCP Scrap Reduction & Output * Internal Auditor ISO 9001:2015 * Production Part Approval Process –PPAP * DFMEA- NPD(New Product Development* Advanced Product Quality Planning -APQP * Supplier Correction Action Request -SCAR* FAI* Value Stream*Project Management* ISO Leadership / Quality Management / Contract Review * Regulatory Compliance * EU MDR SQE/ Manufacturing/ Medical Device*CAPA

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