PROFILE

An experienced quality leader diverse experiences in NPI, customer, supplier, electronics, pharma, medical devices and ISO systems implementation and compliance, allowing me to bring a high level of quality experience to a team in a variety of leadership functions.

PROFESSIONAL EXPERIENCE

Philips

Risk Management Engineer August 2022-Present

Worked with suppliers post release of product

Lead change management team

Pulled together cross functional teams to identify the criticality of an issue and the next steps

Present CAPAs to suppliers, customers, and upper management

Ensure that all the stakeholders including management were aligned with the decision to move forward with a full investigation

Documenting risk assessment utilizing GCP protocols

Conducted PMCF when receiving a customer’s complaint, I worked with the SMEs and cross functional to determine if CAPA was necessary

Private Quality Consulting

Quality Engineer January 2022- August 2022

Assist suppliers in process improvement efforts.

Participated in change management

Assist suppliers in process improvement efforts.

Audited and approved new suppliers focus on GMP. Worked with procurement to create a risk assessment of potential new suppliers.

Was an escalation point for the individual sites in support of site SCARs

Managed supplier CAPAs

Led cGMP training for new employees.

Created supplier KPIs, i.e., PPM, SCAR status and OTD.

Worked with cross functional teams to create PFMEA and DFMEA.

Led (GCP) Good Clinical Practices and conducting risk management

Utilized (GLP) Good Lab Practices disciplines to assist in conducting studies to ensure that quality standards are met

Utilized PSUR to fill in the document to prove pharmacovigilance was being met

Johnson & Johnson Pharmaceutics (Durham, NC)

Supplier Quality Engineer (contractor) October 2021- December 2021

Class III Medical Device

Assist suppliers in process improvement efforts.

In case of non-conformances worked with suppliers to identify a “clean point”

Assist suppliers in process improvement efforts.

Was an escalation point for the individual sites in support of site SCARs

Worked with procurement to create a risk assessment of potential new suppliers.

Worked with plants and suppliers to utilize the 8D, 5Why and A3 processes in addressing field failures and plant failures.

Report-up monthly supplier KPIs, i.e. PPM, SCAR status and OTD.

Utilization of SAP.

ISO, MDD, FDA QSR 21 CFR 820 / ISO 13485 quality system requirements

Managing of MBR

Leading the Board of Change

Managed supplier CAPAs

Utilized GxP

Ensured the Good Clinical Practices

Conducted risk management

Utilized Good Lab Practices

Utilized (GCP) Good Clinal Practice

Conducted risk management

Utilized (GLP) Good Lab Practices

Utilized PSUR to ensure that we were practicing pharmacovigilance

Ensured that the company was EU MDR compliant

UKEA

MDR

Merck Pharmaceutics (Durham, NC)

Quality Engineer (contractor) May 2021 September 2021

Work with the manufacturing floor to investigate quality issues.

Assist suppliers in process improvement efforts

Was an escalation point for the individual sites in support of site SCARs

Worked with procurement to create a risk assessment of potential new suppliers.

Audited and approved new suppliers with a heavy focus in cGMP.

Report-up monthly supplier KPIs, i.e., PPM, SCAR status and OTD.

In case of non-conformances worked with suppliers to identify a “clean point”

Utilization of SAP.

Knowledge of ISO, MDD, FDA QSR 21 CFR 820 / ISO 13485 quality system requirements

Managed plant CAPAs

Utilized Trackwise

Utilized SAP

Utilized GxP

Led (GCP) Good Clinical Practices and conducting risk management

Utilized (GLP) Good Lab Practices disciplines to assist in conducting studies to ensure that specofoed quality standards are met

Ensured that the company was EU MDR compliant

Private Quality Consultant

Quality Engineer January 2019 – April 2021

Worked to introduce an updated gowning process.

Assist suppliers in process improvement efforts.

Assist suppliers in process improvement efforts.

Audited and approved new suppliers focus on GMP. Worked with procurement to create a risk assessment of potential new suppliers.

Was an escalation point for the individual sites in support of site SCARs

Managed supplier CAPAs

Led cGMP training for new employees.

Created supplier KPIs, i.e., PPM, SCAR status and OTD.

Worked with cross functional teams to create PFMEA and DFMEA.

Led (GCP) Good Clinical Practices and conducting risk management

Utilized (GLP) Good Lab Practices disciplines to assist in conducting studies to ensure that quality standards are met

Utilized PSUR to fill in the document to prove pharmacovigilance was being met

ASCOM Healthcare Communications (Morrisville, NC)

Supplier Quality Engineer (contractor) August 2019-December 2019

Support of Class 1 Medical Devices (i.e. Hospital communication equipment)

In case of non-conformances worked with suppliers to identify a “clean point”

Assist suppliers in process improvement efforts.

Was an escalation point for the individual sites in support of site SCARs

Worked with procurement to create a risk assessment of potential new suppliers.

Audited and approved new suppliers focus on GMP.

Worked with plants and suppliers to utilize the 8D, 5Why and A3 processes in addressing field failures and plant failures.

Report-up monthly supplier KPIs, i.e. PPM, SCAR status and OTD.

Utilization of SAP

ISO, MDD, FDA QSR 21 CFR 820 / ISO 13485 quality system requirements

Managing of MBR

Leading the Board of Change

Managed supplier CAPAs

Utilization of Trackwise

In charge of document control

Managed Change Control Board

oLeading cross functional teams to systematically implement change

oUtilizing LEAN to sign off on change

Eaton

Quality/Compliance Engineer (consultant) March 2019-July 2019 (Youngsville, NC)

Scheduled and interfaced with external registrars in the maintenance of the facility’s ISO 9001 certification.

Led management reviews.

Led the offer creation quality leadership team consisting of all the functional managers within the North American design centers (Quality Leadership Team). The purpose was to create best practices, highlight potential issues and to ensure that there was communication throughout the quality management system.

Ensure that all Quality Management System documents such as the Quality Manual meets the requirements of the ISO 9001 registration.

Based upon findings from external and internal audits led root cause analysis and implementation of corrective and preventive actions. This allows each of the North American facilities to maintain their registration.

Participated in Lean and Six Sigma projects.

AsteelFlash

Regional Supplier Quality Engineer June 2018 - January 2019 (Morrisville, NC)

Worked to introduce an updated gowning process

Class II Medical Devices. Units that were ingested into the human body.

AsteelFlash is a contract manufacturer for JUUL Labs Inc.

Support of Class 1 Medical Devices (i.e. the JUUL vaping system)

Audited the document control system

In charge of supporting supplier quality for our manufacturing sites in the Americas; reporting directly to the executive board.

Created and reported up supplier KPIs to the executive board.

Was an escalation point for the individual sites in support of site SCARs

Worked with procurement to create a risk assessment of potential new suppliers.

Audited and approved new suppliers.

Worked with plants and suppliers to utilize the 8D, 5Why and A3 processes in addressing field failures and plant failures.

Identified supplier requirements (PPAP levels, APQP requirements, ISO 9001, ISO 17025, ISO 13485 and TS16949 compliance).

Worked as a liaison between the company and the FDA based upon FDA 21 CFR 820.

Travelled to various suppliers throughout the Americas, Asia and Europe to evaluate and report. Supplier readiness.

Assist suppliers in process improvement efforts.

Led IQPQOQ exercises in an NPI function.

Managed Change Control Board

oLeading cross functional teams to systematically implement change

oUtilizing LEAN to sign off on change

Quality Engineering Supervisor January 2018 – June 2018

Conducted validation of new manufacturing lines utilizing IQPQOQ and gauge R&R analysis.

Conducted validation of manufacturing lines that were moved within the facility.

Provide “one voice” to the customer for any customer induced SCARs.

Conducted bi-weekly meetings with the customer to address and update the status of open quality issues.

Led Kaizen events for continuous improvement on various manufacturing lines.

Assisted in the transition of an electronics contract manufacturer to that of a medical device company; ISO 13485 and 21 CFR part 820.

Addressed quality issues with customers by utilizing standard problem-solving tools such as CAPA, 8D, 5 Why and Fishbone diagrams.

Created SOPs for cleanroom, inspection and automated packaging lines in a high-volume manufacturing environment.

Worked with EHS in writing SOPs addressing accident incidents such as blood borne, ergonomic and orthopedic injuries.

Supervision of 20 Quality Inspectors and Leads on the packaging lines

Supervision of a team of cleanroom Engineering Technicians.

Trained employees on cGMP principles.

Led IQPQOQ exercises in ani NPI function.

Managing of the MRB

Leading the Board of Change

Evaluated the training of employees Ensured that the company was EU MDR compliant

Ensured that the company was EU MDR compliant

Implemented MDR for new facilities plan

Ensure that UKCA requirements are met

Telit Wireless Solutions (Morrisville, NC)

North American Quality Manager/ Quality Management Representative (QMR) July 2017- May 2018

Provided “one voice” to the customer.

Identified supplier requirements (PPAP levels, APQP requirements, ISO 9001, ISO 17025 and TS16949 compliance).

Worked with plants and suppliers to utilize the 8D, 5Why and A3 process in addressing field failures and plant failures.

Managed the North American Quality team.

Trained and evaluated the training of employees.

As the QMR, I led the North American facilities (R&D, Sales, Engineering, and Operations) to achieve its first ISO 9001 registration.

Utilized EtQ for the following purposes.

oUtilized this tool for the housing of documents

oIncluding SOPs, training record, internal and external audit documents including findings

Led (GCP) Good Clinical Practices and conducting risk management

Utilized (GLP) Good Lab Practices disciplines to assist in conducting studies to ensure that specified quality standards are met.

Worked to introduce an updated gowning process

Caterpillar (Clayton, NC)

Supplier Quality Engineer (contract) July 2016- July 2017

Trained smaller suppliers on New Product Introduction (NPI) to ensure that they were prepared to provide APQP/PPAP deliverables.

Trained suppliers in cGMP practices.

Worked with internal Quality teams to sign-off on the work completed by the suppliers to adding the supplier to our Accepted Quality List (AQL).

Worked with plants and suppliers to utilize the 8D, 5Why and A3 process in addressing field failures and plant failures.

Identified supplier requirements (PPAP levels, APQP requirements, ISO 9001, ISO 17025 and TS16949 compliance).

Travelled to various suppliers throughout the United States and Europe to evaluate and report supplier readiness.

Major project was to bring on smaller suppliers in Europe that were not versed in cGMP or any ISO registrations.

Assist suppliers in process improvement efforts.

Led IQPQOQ exercises in an NPI function.

Managing of MRB

Leading the Board of Change

GKN Driveline (Roxboro, NC)

Advanced Quality Engineer (contract) September 2013- May 2016

Conducted validation of new manufacturing lines utilizing IQPQOQ and gauge R&R analysis.

Conducted validation of manufacturing lines that were moved within the facility.

Worked as a liaison between our external customer (Ford Motor Company) and the plants. This often entailed formally communicating tooling, line, and supplier changes through the Ford B2B portal.

Partnered with international cross functional teams as the quality leader; ensuring that all deliverables (PFMEA, DFMEA, PPAP, control plans, etc.) are completed within the required timeframe.

Lead team in APQP efforts.

Created and presented 8D’s, A3’s and other problem-solving tools to GKN’s external customer when addressing quality returns.

Supported the manufacturing lines by creating SOP’s and communicating product performance from the field.

Designed forms for recording, evaluation, and reporting quality and reliability data.

Worked with suppliers on improving quality and conduct internal & external audit and issue reports outlining the results.

Developed and initiate methods, procedures and embedded tests for inspection, testing and evaluation of manufactured products.

Participated in machine/gage evaluations (R&R, Cpk/Ppk studies, etc.).

Co-author PFMEA and Control Plans in collaboration with the cross-functional project team.

Led IQPQOQ exercises in an NPI function.

Managing of MRB

Leading the Board of Change

Schneider Electric North America, Knightdale NC May 2010- July 2013

Quality Engineer

Project Quality Leader (PQL)/Quality Management Representative (QMR)

QMR duties

Worked as a Project Quality Lead leading cross functional teams for the NPI development of the Electric Vehicle charger for the Nissan Leaf and BMW.

Trained the internal audit team to ensure compliance for external audits.

Conducted validation of new manufacturing lines utilizing IQPQOQ and gauge R&R analysis.

Conducted validation of manufacturing lines that were moved within the facility.

The Quality Management Representative for the North American Design Center’s ISO 9001and ISO 17025 registrations. Leading facilities in Monterrey, MX, Cedar Rapids, IA, Nashville, TN, and Raleigh, NC through successful UL and AFNOR ISO 9001:2008 assessments.

Led IQPQOQ exercises in NPI functions.

In preparation for the for the impending revision to the standard became the subject matter expert for the upcoming revision to the standard ISO 9001:2015

Led the offer creation quality leadership team consisting of all the functional managers within the North American design centers (Quality Leadership Team). The purpose was to create best practices, highlight potential issues and to ensure that there was communication throughout the quality management system.

Ensure that all Quality Management System documents such as the Quality Manual meets the requirements of the ISO 9001 or 17025 registrations.

Based upon findings from external and internal audits led root cause analysis and implementation of corrective and preventive actions. This allows each of the North American facilities to maintain their registration.

Participated in Lean and Six Sigma projects.

PQL duties

As a PQL I collaborated with the plants during the offer creation process to ensure that manufacturing is prepared to run at a minimum “first pass yield” of 95%.

Routinely made supplier visits to audit processes and mentor as to what would be expected. This limited the opportunity for miscommunication and unsatisfactory quality at the point of MAKE.

During the offer creation process worked with industrialization to ensure that the supply chain is capable of meeting the expected demand.

Partnered with international cross functional teams as the quality leader within PMP and PEP projects to ensure that all project deliverables are correct, available, and properly reposed (FMEAs, first article inspections, clarifying the Quality Objectives, etc.).

Collaborated with project design engineers when field issues have occurred to determine containment, potential cost and if a recall will be required.

Devised and documented sampling procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data.

Compiled and wrote training materials and conducted training sessions on quality control services for technicians and associates in the Quality Assurance Group.

Utilized EtQ for 13 years

oUtilized this tool for the housing of documents

oIncluding SOPs, training record, internal and external audit documents including findings

Schneider Electric North America, Knightdale, NC May 2001-June 2010

Product Support Engineer

Support of Class 1 Medical Devices (i.e. Line Isolation Monitor utilized in hospital rooms)

Provide engineering support for a range of products specializing in electronics, through all phases of product development and manufacturing including but not limited to medical products, lighting, solid state overload relays, safety relays, light curtains, electric vehicle chargers, etc.

Point person for the UL certification of all medical products developed by Development Engineering ensuring that that the process was successful.

Interfaced extensively with external customers assisting with concerns either by phone or making actual customer visits.

Provide product support through the analysis, evaluation and producing of written reports for customer returns.

Handle customer warranty issues, including final decision making on the determination of credit.

Work with the manufacturing facilities and expert centers internationally to generate containment and corrective actions for non-conforming products.

Communicate the status of field failure rates, dispositions, and corrective and containment actions to management.

Utilized EtQ for 13 years

oUtilized this tool for the housing of documents

oIncluding SOPs, training record, internal and external audit documents including findings

Newport Technology (A contract manufacturing firm), Raleigh, NC July 2000-May 2001

Manufacturing/Test Engineer

Provided technical expertise in testing and product knowledge for a contract manufacturing company.

Offered accurate estimates and reports of test progress, yields and rates.

Wrote and assisted in the development of test plans and test procedures.

Managed the defect database under the guidance of senior QA engineers.

Reviewed test procedures for accuracy and relevance.

Interfaced with various departments including design, manufacturing and QA.

Assisted manufacturing with test and end of line failure solutions.

Mitsubishi Semiconductor of America Inc., Durham, NC June 1997- July 2000

Reliability Quality Assurance Engineer

Supported standards and methods for inspection, testing and evaluation of DRAMs and Memory Modules utilizing knowledge in engineering fields such as chemical and electrical.

Analyzed, evaluated and provided written reports, disposition and corrective actions for external customers and management on DRAM and Memory Module field failures.

Provided a statistical overview of the field failure rates as well as manufacturing quality rates in a report to management in a monthly engineering meeting.

Worked as an internal auditor to ensure that Mitsubishi Semiconductor maintained its ISO certifications.

Supported technicians in the maintenance and repair of the reliability equipment i.e temperature and humidity chambers, temperature shock, burn-in ovens etc.

Utilized (GLP) Good Lab Practices disciplines to assist in conducting studies to ensure that specified quality standards are met

EDUCATION

Colorado Technical University, Colorado Springs, CO 2009

MBA with a concentration in Logistics Engineering and Supply Chain Management

Thesis topic: The Importance of Attaching a Monetary Value to Supply Chain Inefficiencies and Improvements

Strayer University, Washington, DC B.S in International Business summa cum laude 2002

North Carolina A & T State University, Greensboro, NC, B.S in Industrial Technology (electronics) 1997

Durham Technical Community College, Durham, NC A.A.S. Electrical Engineering 1994

Enterprise Quality Management Solutions Utilized

Trackwise

Excellence Through Quality (EtQ)

Quote To Cash (Q2C)

Expertise in Excel (vlookups, pivot tables)

Power Point

Data Analytics Software’s such as Power BI and Tableu

CERTIFICATIONS AND ACCREDITATIONS

ISO 16949 auditor

ISO/IEC 17025 certified auditor

Exemplar Global certified ISO 13485:2016 certified lead auditor (cert #200229)

Exemplar Global certified ISO 9001:2015 certified lead auditor (cert #200229)

PROFESSIONAL MEMBERSHIPS

Member of Technology Professional Services Association

Member of International Society of Logistics Engineers

American Society of Quality

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