Experience

Longenecker & Associates, Inc.

• United States
• Business Consulting and Services
• 100 - 200 Employee

• Senior Quality Assurance Engineer/Lead Auditor

  • Sep 2021 - Present

  2514 Red Arrow Drive, Las Vegas, NV 89135 Lead and support Department of Energy [DOE] 414.1D and ANSI N45.2 and 10CFR830, ASME NQA-1 supplier performance-based audits on behalf of the Mission Assurance Business, Triad National Security LLC at the Los Alamos National Laboratory NM. Perform interrelation reviews of quality assurance regulatory/contractual/technical documents (i.e., orders, DOE Order 414.1, 10CFR830, ASME NQA-1, contractual requirements relevant to quality assurance activities). Conduct audits and gap assessments… Show more Lead and support Department of Energy [DOE] 414.1D and ANSI N45.2 and 10CFR830, ASME NQA-1 supplier performance-based audits on behalf of the Mission Assurance Business, Triad National Security LLC at the Los Alamos National Laboratory NM. Perform interrelation reviews of quality assurance regulatory/contractual/technical documents (i.e., orders, DOE Order 414.1, 10CFR830, ASME NQA-1, contractual requirements relevant to quality assurance activities). Conduct audits and gap assessments of quality management systems, and other related projects per applicable requirements and regulations, including but not limited to the US FDA CFR, Medical Device Single Audit Program (MDSAP), and international quality system standards (e.g., ISO 9001:2015) to ensure compliance to all applicable quality and regulatory requirements. Schedule and plan the review of technical documentation, assess corrective action responses, and provide constructive feedback. Assist the management team and staff members to drive continual improvement with incumbent expectations to utilize Change Order processes to improve and update policies, procedures, work instructions, and templates. Direct and assist other quality engineers, quality specialists, and technical specialists in the planning, performing, and reporting of suppliers and internal independent assessments, surveillances, and audits. Conduct risk-based gap analysis to advance regulatory compliance to identify and report systemic compliance issues or gaps Independently verified Nuclear Project procedures and activities that affect quality as well as test procedures for establishing Nuclear Quality Assurance witnessing and/or Hold Points. Coordinate with stakeholders to lead and manage cross-organizational teams to audit projects by developing and executing audit plans. Assure adherence to company, regulatory, and quality standards, and provide quality-driven assessments to qualify suppliers. Show less



R. J. Reynolds Tobacco International, Inc.

• Lead Manager of QA Supplier Audits

  • Apr 2018 - Nov 2021

  Greensboro/Winston-Salem, North Carolina Area Performed domestic and international corporate supplier quality assurance audits on behalf of the Scientific & Regulatory Affairs Division to assure site compliance with local and federal regulations and requirements i.e., ISO 9001, ISO 13485, cGMP, and HACCP as well as agreed upon site-specific specifications. Managed the supplier quality assurance program that encompasses GxP regulations to assure a robust assessment of suppliers for new business, new products, and current… Show more Performed domestic and international corporate supplier quality assurance audits on behalf of the Scientific & Regulatory Affairs Division to assure site compliance with local and federal regulations and requirements i.e., ISO 9001, ISO 13485, cGMP, and HACCP as well as agreed upon site-specific specifications. Managed the supplier quality assurance program that encompasses GxP regulations to assure a robust assessment of suppliers for new business, new products, and current production. Facilitated TPMP readiness inspection gap assessments with outside services that included quality, independence, authorities, resources, staff competencies, and core-quality process. Cross-functionally and collaboratively provided leadership and applicable regulatory guidance (BRC, FSSC 22000, FDA 21CFRs, EU, ISO, and cGMP) across the shared service companies. Managed the stewardship, data/product integrity, quality and R&D workflows, stage and gate tasks, and processes in the online supplier qualification and requalification software application. Strategically managed supplier audit schedules, audit plans, audit reports, CAPA responses, and communicate audit results and performance metric drivers to senior management. Led department and cross-functional quality assurance initiatives to sustain systems and practices which meet FDA and competent authorities in the EU, and China as well as address supplier-related quality adversities. Provided pertinent quality data/metadata to extrapolate factual decisions based on established key supplier performance indicators. Led/supported business initiatives to promote and nurture a supplier/customer partnership based on a center of excellence approach. Developed and maintained Supplier Quality Agreements based on current regulations including, but not limited to FDA and ISO. Show less



Fontem Ventures B.V.

• Netherlands
• Manufacturing
• 1 - 100 Employee

• North America, Senior Quality Engineer

  • Oct 2017 - Apr 2018

  Charlotte, North Carolina Area Communicate with vendors regularly to address any concerns and foster an environment that facilitates continual improvement in working relationships. Maintain a supplier database and include performance evaluations and quality systems audits in the database for in-house access by company personnel. Performed Process Control Audits and executed Proactive Problem-Solving Initiatives. Successfully collaborated with customer service and internal teams to investigate and resolve… Show more Communicate with vendors regularly to address any concerns and foster an environment that facilitates continual improvement in working relationships. Maintain a supplier database and include performance evaluations and quality systems audits in the database for in-house access by company personnel. Performed Process Control Audits and executed Proactive Problem-Solving Initiatives. Successfully collaborated with customer service and internal teams to investigate and resolve consumer/customer complaints. Authorized the release of products from Accredited Laboratories and Manufacturing facilities. Show less



ADAMA Ltd.

• Israel
• Farming
• 700 & Above Employee

• Quality Compliance Professional

  • Jan 2017 - Sep 2017

  Analyzed Certification Statement Formulation (CSFs) to ensure EPA compliance. Conducted internal and external quality audits to drive continuous improvement and optimum supplier performance. Effectively managed the US and Canada policies and standards operating procedures as well as the corrective action program. Monitored State and Federal Regulatory EPA change requests to ensure correct manufacturing usage. Managed and reported established quality KPIs and Cost of Poor Quality… Show more Analyzed Certification Statement Formulation (CSFs) to ensure EPA compliance. Conducted internal and external quality audits to drive continuous improvement and optimum supplier performance. Effectively managed the US and Canada policies and standards operating procedures as well as the corrective action program. Monitored State and Federal Regulatory EPA change requests to ensure correct manufacturing usage. Managed and reported established quality KPIs and Cost of Poor Quality at senior management meetings. Contributed to the development of quality strategy and implemented tactical plans for improvement at the R&D sites. Contributes to the accuracy and completeness of the regulatory document library by ensuring that pertinent corporate standards and functional regulatory procedures are documented, thereby facilitating knowledge transfer, capability, and capacity enhancements. Show less



ZF Group

• Germany
• Motor Vehicle Manufacturing
• 700 & Above Employee

• Quality Supplier Professional

  • Mar 2016 - Dec 2016

  Duncan SC Performed critical tasks from concept approval through production using the APQP/PPAP process to launch new products in accordance with applicable requirements i.e., product and process design development, validation, and corrective action. Monitored and supported the approval process of supplier PPAP's for Engineering Changes to new and modified parts. Tracked supplier performance through monthly Key Performance Indicators (KPIs) in conjunction with Corporate Supplier… Show more Performed critical tasks from concept approval through production using the APQP/PPAP process to launch new products in accordance with applicable requirements i.e., product and process design development, validation, and corrective action. Monitored and supported the approval process of supplier PPAP's for Engineering Changes to new and modified parts. Tracked supplier performance through monthly Key Performance Indicators (KPIs) in conjunction with Corporate Supplier Group. Performed initial problem investigation and containment activities at the plant or program site for purchased direct materials. Conducted periodic audit of supplier facilities to assess capabilities, adequacy, quality control, and compliance to specifications. Initiated supplier-related 8D's to resolve quality discrepancies and ensure implementation effectiveness and timely CA closure. Interfaced with Quality Engineers, inspectors, production associates, and suppliers to provide solutions to customer complaints. Show less



TOSHIBA AMERICA BUSINESS SOLUTIONS

• Manager of Nuclear & ISO/TS Quality Systems

  • Apr 2012 - Feb 2016

  Charlotte, North Carolina Area Developed a quality assurance program that supplies items and services that provide a safety function for nuclear facilities in conformance with the requirements of the ASME NQA-1 standard. Conduct risk-based gap analysis/audits to advance regulatory compliance with tier 1 suppliers while recommending and implementing customer-specific consultations. Responsible for supplier management including qualifying new suppliers to improve marginal supplier performance as well as to conduct root… Show more Developed a quality assurance program that supplies items and services that provide a safety function for nuclear facilities in conformance with the requirements of the ASME NQA-1 standard. Conduct risk-based gap analysis/audits to advance regulatory compliance with tier 1 suppliers while recommending and implementing customer-specific consultations. Responsible for supplier management including qualifying new suppliers to improve marginal supplier performance as well as to conduct root cause analysis for non-compliant/adverse conditions. Acted as a liaison to leverage knowledge in centralized logistic departments to foster behaviors conducive to achieve sustainable success. Responsible for measured supplier performance against established Key Performance Indicators, objectives, and budgets. Established and implemented communication strategy for the improvement and awareness of quality issues across supplier base. Led supplier cross-functional teams to achieve quality excellence and drive positive scorecard performance. Established healthy relationships to enhance the customer’s confidence which resulted in a decrease in customer nonconformance. Qualified logistic supplier for Barge, Truck, and Rail transportation modes. (i.e., Barnhart, Landstar, and Specialized Rail Transport). Show less



The Shaw Group

• Senior Quality Engineer/Lead Project Auditor

  • Jul 2011 - Jun 2012

  121 W Trade Street, Charlotte Responsible for ensuring that NQA-1, 10 CRF50 Appendix B requirements were invoked on Suppliers as well as Nuclear Projects. Performed qualification and implementation quality assurance programmatic audits in accordance to (NQA-1of ANSI N45.2, 10CFR50 Appendix B, ASME Section III, and ISO 9001:2008). Performed audit surveillances, source inspections as a means of independently verifying Project Quality compliance to, 10CFR50, Appendix B, and ASME NQA-1 such as assuring Part 21 is invoked… Show more Responsible for ensuring that NQA-1, 10 CRF50 Appendix B requirements were invoked on Suppliers as well as Nuclear Projects. Performed qualification and implementation quality assurance programmatic audits in accordance to (NQA-1of ANSI N45.2, 10CFR50 Appendix B, ASME Section III, and ISO 9001:2008). Performed audit surveillances, source inspections as a means of independently verifying Project Quality compliance to, 10CFR50, Appendix B, and ASME NQA-1 such as assuring Part 21 is invoked in supplier’s purchase orders. Independently verified Nuclear Project procedures and activities that affect quality as well as test procedures for establishing Nuclear Quality Assurance witnessing and/or Hold Points. Prepared Nuclear Corrective Actions in support of Quality Assurance activities that were found to be noncompliant to the Nuclear Project Quality Assurance requirements, Corporate Global Nuclear Procedural requirements, 10CFR50 Appendix B, and/or ASME NQA-1 requirements. Also assisted with the resolution of non-conformance issued by the Nuclear Regulatory Commission (NRC). Show less



Parsons Corporation

• United States
• Professional Services
• 700 & Above Employee

• Quality Lead Auditor/Engineer

  • Apr 2008 - Jul 2011

  Charlotte, North Carolina Area Responsible for the integrity of the Quality System in the corporate office with the influences of project audits. Implemented quality assurance/control (QA/QC) programs complying with (NQA-1-1994, 2008, 10CFR50 Appendix B, ASME Section III, ANSI N45.223and ISO 9001:2008). Led the qualification and audit process of supplier programs by performing audits and surveillances to ensure requirement flow down and responded to client and supplier inquiries regarding quality assurance subjects… Show more Responsible for the integrity of the Quality System in the corporate office with the influences of project audits. Implemented quality assurance/control (QA/QC) programs complying with (NQA-1-1994, 2008, 10CFR50 Appendix B, ASME Section III, ANSI N45.223and ISO 9001:2008). Led the qualification and audit process of supplier programs by performing audits and surveillances to ensure requirement flow down and responded to client and supplier inquiries regarding quality assurance subjects and concerns. Show less