Quality Assurance

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Posted:

December 24, 2024

Resume:

Overview

Ms. Byle is a degreed, published, professional with a B.S. in Computer Science. She brings over 25 years of experience in the areas of quality assurance and safety, with a specialty in Software Quality Assurance (SQA), supporting a variety of federal and commercial organizations and projects with an emphasis on the nuclear industry. This includes recent, relevant experience providing safety and non-safety Quality Management Systems (QMS) and regulatory program implementation in support of GE Verona Nuclear, Hanford National Lab, and Los Alamos National Laboratories (LANL). She has a proven track record of successfully delivering regulatory, quality, and safety compliant programs. She has worked under many different standards and for multiple industries, while ensuring that the needs and expectations of customers and stakeholders were satisfied.

Ms. Byle holds a Nuclear Quality Assurance (NQA-1) Lead Auditor Certification and an American Society for Quality Certified Software Quality Engineer (ASQCSQE) certification.

Ms. Byle has experience on all levels of quality and safety. This includes authoring and reviewing, all levels of documentation to ensure compliance with upper tier regulatory and business requirements. This has included Quality Assurance Program Documents (QAPDs), implementing procedures, and work instructions. She has experience participating in design reviews, product release reviews, and contract review. She has supported established quality programs and led the creation of QMSs starting from scratch. She has transitioned quality assurance programs from research to regulatory under standards and requirements such as ASME NQA-1, ISO 9001, DOE Order 414.1D, 10 CFR 50 App B, and 10 CFR Part 21.

Ms. Byle is a contributing member on the ASME NQA-1 Software Quality Standard’s Committee. The NQA Standard is the standard upon which the ISO qu2ality standard was developed. including Part 1 Requirement 3 Desing Control, Requirement 11 Test Control, Subpart 2.7 Software Quality, and Subpart 2.14 Commercial dedication. She is a listed author on a number of the ASME NQA versions, including the commonly implemented 2015 version, that references a commonly used version of the ASME Boiler Pressure Vessel Code. Her participation on a quality standards committee keeps her proficient in a number of related standards such as IEEE and ISO.

Quality

Ms. Byle has designed, deployed, and monitored a variety of Quality Management Systems (QMS) to provide quality assurance support and regulatory compliance for a variety of organizations including recent experience at: GE Verona Nuclear, Hanford, Oak Ridge National Laboratory, Los Alamos National Laboratory, Lawrence Livermore National Laboratory, Sandia National Laboratory, the Kansas City National Security Campus.

She has supported projects at the Department of Energy (DOE), the Department of Defense (DOD), the Environmental Protection Agency (EPA) and many National Nuclear Security Administration (NNSA) sites and facilities nationwide, providing her extensive experience with creating, using, and maintaining QMSs for federal agencies.

This experience has helped her become adept at learning and implementing new standards.

She has experience in Non-Conforming Material Reports (NCMR), regulatory experience as Quality Lead for the compliance recertification application for the Waste Isolation Pilot Plant (WIPP), Corrective Action Preventive (CAPA), Commercial Grade Dedication, and extensive validation experience.

Management

Her ten plus years of management experience includes creating large multidisciplinary technical project teams, of up to 50 staff and contractors, with progress, budget, hiring and termination responsibilities.

Ms. Byle’s management experience includes building large project teams encompassing a variety of technical and quality experience. Ms. Byle has ten years experience managing quality department budgets and schedules. She has over 20 years experience generating progress, budgetary, and quality reports for senior and executive management, suppliers, and stakeholders.

Throughout her career, she has been responsible for tracking both product and quality deliverables. Ms. Byle’s experience serving in management and lead positions have required excellent collaboration and communication skills, and she has extensive experience in conflict resolution, as well as communicating with and reporting to upper management, stakeholders, regulators, auditors, and staff.

Auditing

Ms. Byle has over twenty years of experience auditing programs based on national and international standards including: ASME, IEEE, International Standards Organization (ISO), and Candain Standards (CSA). This experience includes extensive experience in the corrective action process, root cause analysis, and PART 21 safety reporting.

Ms. Byle has successfully defended quality program implementation in audits conducted by external parties, including the DOE, the Nuclear Regulatory Commission (NRC), ISO, and the Environmental Protection Agency (EPA).

Education, Qualifications, and Certifications

B.S. Computer Science, College of Engineering, University of New Mexico, 1989

Certified NQA-1 Lead Auditor

American Society for Quality Certified Software Quality Engineer (ASQCSQE) ID 6690

ISO Qualified Auditor

CMMI Qualified Auditor

Software Competencies

Microsoft Office Suite, Visio

Gensuite

SharePoint

DevonWay

Agile/ Scrum

Confluence

PLM

PV Elite®

Costpoint

CAESAR II®

Work Experience

Sr Quality Manager - Industry Standards Compliance 07/2022 – 06/2024

GE Vernova Nuclear, Wilmington, NC · Full-time Remote

Responsible for making high level decisions regarding the technical and quality make up of audit teams for both internal and external audits. Responsible for the conduct and outcome of audits including the issuance of corrective actions, the evaluation of Part21, and the issuance of audit reports to senior management and stakeholders.

Responsible for creating, implementing, auditing, and controlling QA, SQA and quality control plans and activities for nuclear power plant design/development and deployment of projects, and enterprise applications for manufacturing process controls, material control, and configuration control.

Participate in Kaizen events and develop Key Performance Indicators (KPIs) for the quality auditing program. Conduct design reviews and provided technical and quality discipline oversight for Human Factors Engineering (HFE), Instrumentation Control (I&C), Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), simulation, Software as a Service (SaaS), and enterprise applications as required. Software included a range of types and characteristics across a broad spectrum of technologies.

Responsible for coordinating requirements management for each product from initiation to release to ensure compliance with design control and quality assurance, using Project Lifecycle Management (PLM) software

Support projects that use design and analysis software and that include the release of products that include software and embedded software. Assigned to the Oracle and Natrium Projects.

Participated in GE safety program ensuring nuclear and OSHA regulatory requirements were met. Ensured software compliance with regulatory requirements, contractual requirements, industry standards, and best practices. Coordinated, developed, and integrated quality requirements, processes, and deliverables with engaged teams.

Audited, assessed, and reported ongoing performance to leadership for all related activities against approved plans for both internal and external projects throughout the software development and maintenance lifecycle. Served as a best practice and quality resource. Contributed to strategy and policy development and ensured delivery within area of responsibility. Participated in conflict resolution.

Effectively communicated complex messages to all levels of the organization. Acted as a resource for colleagues with less experience. Influenced others and built consensus on topics within expertise. Offer insightful perspectives on existing solutions. Developed and deployed Quality Assurance training for engineering and quality staff.

Professionally represented GE Hitachi (GEH) Nuclear Energy in supporting external, customer, and regulatory assessments and visits. Provided quality support for all types of software, including design and analysis, embedded, digital, and control.

Responsible for all eighteen elements of NQA quality program, including: corrective action, auditing, control of Measuring and Test Equipment (M&TE,) procurement document control/ document control, commercial grade dedication, design control, inspection, and quality assurance records.

Senior Quality Engineer 08/2021 – 07/2022

Longenecker & Associates, Los Alamos National Laboratory · Full-time Remote

Monitored every phase of the development process to ensure that design and software activities and documentation adhered to standards (ISO, NQA, DOE.) Participated in safety program ensuring Nuclear and OSHA regulatory requirements were met. (NQA, DOE)

DevonWay administer responsible for coordinating requirements management and customization of the DevonWay product to ensure compliance with design control and quality assurance.

Ensured procedural and regulatory compliance and made safety, security, and quality an integral part of every task. Mentored, developed, and deployed quality assurance training for engineering and quality staff. Developed software quality assurance training for technical and management staff. Worked with developers to produce lifecycle test cases and documentation. Led assessments of various activities with a focus on software and reported results to senior management. Performed requirement management for customization of DevonWay. Recognized for contributions to safety protocol.

Software Quality Assurance 08/2020 – 07/2021

Hanford Mission Integrated Solutions (HMIS), Hanford Site · Full-time Remote (part-time)

(subcontractor 08/2020 – 01/2021, hired direct by HMIS 01/2021 – 07/2021)

Supported development of the HMIS software quality program using a graded approach in alignment with NQA-1, ISO, DOE O 414.1D, and IEEE Std 830-1998 standards. As Test Lead, designed and conducted user interface test cases using Team Foundation Server to generate acceptance test reports for DevonWay iCAS, an integrated business intelligence suite.

Interfaced with testers, developers, and subject matter experts to produce workflow business rules and software development life cycle documentation. Authored desk instructions and templates for best testing practices and guidelines. Involved in reviewing and updating Software Quality Program. Developed computer based, role-based user training to address both NQA and DOE graded approach requirements.

Responsible for coordinating requirements management using DevonWay to ensure compliance with design control and quality assurance.

Supported both safety and non-safety SQA program implementation. Participated in Hanford safety program.

Quality Assurance Program Manager 08/2014 – 08/2020

KB Consulting · Full-time Remote/ On-Site at Oak Ridge and Los Alamos

Analyzed and improved clients’ quality assurance processes. Developed customized procedures and training in the areas of organization of quality assurance program, procurement, audits, scientific notebooks, and software.

Served as management consultant interfacing and working with organizational executives, senior management, and senior technical staff. Provided clients with post-audit support. Ensured client procedures were compliant with any government and corporate upper-tier requirements and regulations while being user-friendly. Mentored clients in achieving staff training and certification goals.

Consulted on program development compliance to a variety of regulatory and quality requirements including ASME NQA-1, ISO 9001, DOE Order 414.1D, 10 CFR 50 App B, and 10 CFR Part 21. Provided consultation for regulatory, quality, and safety requirements.

Responsible for coordinating requirements management for each project from initiation to completion.

Evaluated safety program ensured regulatory requirements were met. Effectively communicated complex messages to all levels of the organization. Acted as a resource for colleagues with less experience. Influenced others and built consensus on topics within expertise. Offered new perspectives on existing solutions.

Represented client company in supporting external, customer, and regulatory assessments and visits. Provided quality support for all types and grades of software, including safety, mission critical, information technology, design and analysis, embedded, digital and control.

Responsible for developing a program to include all eighteen elements of NQA quality program, including: corrective action, auditing, control of Measuring and Test Equipment (M&TE,) procurement document control/ document control, commercial grade dedication, design control, inspection, and quality assurance records.

QA Program Manager 01/2011 – 03/2014

Hexagon PPM (Formally Intergraph Process, Power & Marine)

Developed and implemented an ISO compliant quality program. Oversaw software quality program using Agile/ Scrum. Developed ISO compliant quality program and received ISO certification for pipe stress design and analysis software (CAESAR II®,) and pressure vessel software (PV Elite®.) Oversaw successful transition of CAESAR II® from ISO to NQA-1

Developed a web page for staff access to testing, results, and quality assurance procedures. Utilized SharePoint for software baseline configuration management. Responsibilities included oversite of testing, training, records, and assessments.

Assisted with marketing in content for software quality-related press releases. Presented webinars covering company approach in regard to compliance with ISO and NQA-1 for national and international clients. Attended conferences presenting company’s approach to quality. Attended industry conferences to present company approach in regard to compliance with ISO and NQA-1. Provided presentations to customers at company conferences.

Accepted into ASME standards committee. Collaborated with cross-functional teams, including Product Management, Development, Marketing, and Customer Support, to define and refine product requirements and acceptance criteria. Managed resource allocation and project prioritization within the QA team

Lead Quality Assurance Engineer 06/2008 – 08/2008

Aspen Avionics, Albuquerque, NM

Provided oversight of quality assurance program compliant with D0-178B. Participated in testing and product release of the company’s electronic flight displays.

Senior Software Quality Assurance Engineer 11/2007 – 04/2008

OPNET, Albuquerque, NM

Served as Lead Software Quality Specialist in support of Forest Service (FS) Albuquerque.

Consulted in the centralization of the FS-wide PC operational image development facility.

Developed quality assurance procedures for the reporting process to the FS Leadership team.

Senior Software Quality Assurance Analyst 01/2007 – 08/2007

Cimetrix Inc., Salt Lake City, UT

Provided oversight of quality assurance and business procedures governing motion control software, including writing developer’s instructions that accompanied product release.

Senior Member of Technical Staff (SMTS) 10/1997 – 10/2006

Sandia National Laboratories (SNL), Albuquerque, NM

Interfaced with external customers, stakeholders, and lead technical teams. Effectively communicated complex messages to all levels of the organization. Acted as a resource for colleagues with less experience. Influenced others and built consensus on topics within expertise. Offered new perspectives on existing solutions.

Represented SNL in supporting external, customer, and regulatory assessments and visits. Provided quality support for all types of software, including design and analysis, embedded, digital, and control. Managed project budgets and participated in performance reviews of team members. Qualified for hire under the performance-based program.

Responsible for coordinating requirements management for each project from initiation to completion.

Served as Project Lead for the Corporate Information Open Architecture team, managing the review, approval, and introduction of new technologies to the SNL Common Operating Environment.

Served as Senior Software Quality Engineer for the Software Quality Engineering Department.

Provided software quality support for numerous departments at SNL. Oversaw weapon inspections to ensure quality assurance procedures were followed.

Performed CMM assessment of ICADS CMM Quality Program, which is the ICADS project developed software that was uploaded to Air Force Satellites to monitor compliance with the nuclear test ban treaty. Reported results to Sandia VPs.

Served as Software Quality Lead to the SNL IDART Red Team. Responsibilities included developing processes for use by SNL’s Red Team and participated in simulation attacks on external computer systems to identify weaknesses in computer security. Trained as an “anti-terrorist” to break into computer systems to identify security weaknesses. This project included the development of a workshop for DARPA for a week-long workshop conducted in Washington DC for various federal agencies.

Participated in IT Management Assessment of the Bureau of Reclamation (BoR). Reported results to the BoR Commissioner.

Served as the Software Quality Lead for Corporate Information Department (CID) in charge of revising CID QA program to achieve CMM level 3. Served as the Quality Lead for the Accelerated Software Computer Initiative (ASCI) project. Developed a CMM based assessment process, trained assessment team, and conducted and reported assessment results to SNL Management. Served as ASCII project and technical lead tasked with developing a software quality assurance program. Provided quality assurance training for technical staff.

SNL Waste Isolation Pilot Plant (WIPP) Quality Assurance Lead

Served as Quality Assurance Lead through the completion of the Compliance Recertification Application (CRA) for the WIPP Site. Directed the quality assurance staff and recruited team members. Served as primary interface during audits conducted by the DOE, and as primary interface for inspections conducted by the regulator (EPA).

Request by DOE Carlsbad Field Office to temporarily serve as quality assurance advisor to the Los Alamos National Laboratory (LANL) Carlsbad program until the LANL quality assurance program achieved compliance with NQA-1. Duties included evaluating the current state of the LANL QA program, identifying deltas for compliance, training staff in document control, laboratory practices, and record requirements. Assisted LANL in removing four stop-work orders. Brought laboratory practices into regulatory compliance using Good Laboratory Practices (GxP/GLP). Trained laboratory staff to conduct and document experiments following GLP. Prepared workshops for international audiences, including Japan and Germany. Successfully led the effort to reduce entire Sandia WIPP quality assurance program by 75% while maintaining regulatory compliance. Managed resource allocation and project prioritization within the quality assurance team.

Served as Lead Software Quality Engineer. Responsible for developing software quality processes, database procedures, and ensuring that the approximately 50 modeling and simulation codes were tested and validated in accordance with upper-tier regulatory (NQA-1) requirements. Served as primary customer interface for the software program, and qualification of existing date program during audits.

Quality Engineer 01/1995 – 10/1997

John Hart and Associates, Albuquerque, NM

Served as Lead Software Quality Engineer in support of the SNL WIPP project. Supported areas of NQA-1, specializing in the development of software and analyses procedures. Responsible for the software section of the Compliance Certification Application (quality assurance sections). Trained technical staff. Obtained certification as a Lead NQA-1 Auditor. Conducted contractor audits.

Research Scientist – New Mexico Engineering Research Institute (NMERI)Research Scientist – New Mexico Engineering Research Institute (NMERI) 01/1990 – 01/1995

University of New Mexico

Served as Network Manager and designed and oversaw implementation of network for the newly constructed UNM Research Park. Supervised technicians installing network. Elected to UNM staff council member. Submitted proposal and was awarded the SNL WIPP Project. Software Owner of LHS code.

Awarded the NORAD Projects (contractor to Air Force Space Command). Designed, implemented, tested, and wrote documentation for: software based central environmental control system for entire facility, software-based security access system, and fire evacuation system.

Quality System Engineer 01/1987 – 12/1989

Midco, Albuquerque, NM

Designed user interface for Computer Assisted Stereotactic Surgery (CASS) system. Produced user documentation and operated the system during surgeries. Interfaced with stereotactic surgeons to determine required functionality of the system. Responsible for CASS system compiling with FDA requirements for non-intrusive medical devices.

Performed daily regression testing of User Interface for consistency and compliance to company standards. Trained the medical staff and neurosurgeons in the operation of the software during surgery. Operated the CASS system for surgeons during stereotactic surgeries.

Attended annual neurological conferences to demonstrate the CASS system, conducted technical sessions of the capabilities of the system, and presented papers. Developed quality program compliant with 21 CFR 820, ISO 13285, and ISO 27001.

Led the preparation, submission, and negotiation of regulatory documents, ensuring timely and successful approvals. Coordinated with regulatory authorities. Monitored and interpreted regulatory developments and trends, advising General Counsel and Leadership Team on potential impacts. Collaborated with cross-functional teams, including R&D, Product, and Marketing to integrate regulatory requirements into product development processes.

Implemented robust risk management practices to identify and mitigate regulatory risks. Ensured alignment with quality management systems and regulatory standards. Oversaw regular audits of the departments to ensure compliance with procedures. Provided input into the department budgeting process. Developed and implemented regulatory strategies to ensure compliance with global regulatory requirements for medical devices.

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