Linda Henderson Email and Phone Number

Responsible for developing, leading, overseeing, managing, and implementing the Quality Management System for RMPDS.• Oversees all aspects of the organization’s quality or business improvement efforts and facilitates change throughout the organization. • Provides oversight, direction, management and/or supervision for quality assurance and regulatory compliance.• Plans, develops, and directs quality assurance policies, programs, and initiatives. • Manages vendor approval and serves as Lead Auditor for vendor compliance audits. • Manages Corrective and Preventive Actions (CAPA) program through reviews, facilitation of root cause investigation and action plans, and closure. • Writes and/or reviews software validation documents. • Coordinates and manages customer audits, certification audits or inspections.• Develops strategies for maintaining and expanding the RMPDS QMS and provides oversight and management of all related activities. • Oversees the development, implementation, training and maintenance for all departmental version controlled documents.

Responsible for the administration and supervision of RMPDS Quality Assurance activities, including audit activities and corrective actions. Makes recommendations for cost efficiency and process improvement.• Quality Auditor for internal and supplier processes. Documented findings; managed corrective actions of internal, vendor, client and regulatory authority audits.• Conducted assessment activities including internal quality audits and supplier assessments.• Assisted with preparation of regulatory documents. Developed/revised QA documents, including QA Plan/Manual, procedures and supporting documents.• Managed nonconformance process, database and documentation.• Conducted investigations into nonconformities and supplier issues in accordance with established CAPA procedures.• Ensured the company keeps abreast with current regulatory requirements including FDA, ISO, etc.• Evaluated process deviations and determines appropriate actions.

Provide contracted support on various projects including, but not limited to:• Content research and development for regulatory libraries.• Asset-risk library development/update.• OpenPages and financial services data development.• Risk methodology documentation update for application to ISO 9001:2015.• Consult/assist companies in implementing ISO 9001:2015, including identification and development of key business processes.• Training program development focused on risk management and quality management systems.

Managed AWS certification and accreditation programs for facilities and individuals.Key accomplishments:- Redesigned & executed the audit program, establishing performance metrics & consistency throughout the audit process, resulting for 3 AWS facility accreditation programs.- Developed & delivered a 3-day training program for 30+ auditors.- Conceptualized, developed & implemented process improvements to streamline robotic test center approval. Changes dramatically improved program effectiveness, resulting in 2 new centers.- Project Manager for redesigning the Certified Welding Inspector practical exam to maintain the integrity of AWS’s top revenue producing program. Managed budgets, contracts, RFI/RFQ, POs for test kits, change orders, & committee activity/meeting minutes. Led staff activity for developing exams. Monitored project, ensuring cost & quality plans were carried out.- Collaborated with the Marketing team in executing promotions for 9 certification/accreditation programs.Responsibilities:• Supported Certification Committee, as needed.• Coordinated activities of 10+ program subcommittees for development of new/revised programs & supporting standards.• Developed, implemented, & oversaw auditing program and supporting processes. Managed, evaluated, & hired auditors for AWS accreditation programs.• Supported Sr. Associate Executive Director and Certification Operations by providing new product information and customer support business processes, setting up systems, and delivering events & training for new or existing products and programs.• Assisted Sr. Associate Executive Director on special projects, planning events, District/Section & international activity.• Managed marketing initiatives for certification programs in collaboration with the Education Department & provided guidance & feedback on marketing for accreditation programs.

Managed marketing development and implementation of marketing plans for AWS certification and education programs. Key accomplishments:- Formalized the process of establishing annual marketing plans for the Certification & Education Departments.- Developed methods & provided product analysis, copy, & design specifications for direct mail collateral from conception to production, including RFQ submittal, RFI coordination & tracking costs.- Reduced the cancellation of conferences due to low registration by 50%.Responsibilities:• Managed & tracked advertising, direct mail, email and website marketing projects for revenue programs of the Certification & Education departments & other areas, as needed.• Coordinated direct mail and email.• Tracked effectiveness of marketing efforts.

Managed of all aspects of the staff & volunteer quality program operations & projects.Key accomplishments:- Worked with executive management to develop & coordinate an improved long-term strategic planning & annual goals setting process, including measurable goals for accountability.- Led AWS Headquarters & 19 departmental teams in the implementation & attainment of ISO 9001 certification.- Established & managed a company-wide QA/QC program & established performance metrics, resulting in a streamlined process for improved performance of the quality management system (QMS) & effective management of policies, procedures, assessment, & corrective/preventive action (CAPA).- Implemented & managed Human Resource programs required for ISO 9001 certification, including employee recognition, performance evaluation, employee policy, workshops & training programs.- Through extensive research, discovered and implemented time-saving solutions for streamlining policies, procedures (SOPs), corrective/preventive action (CAPA), quality control, internal assessment and process workflow.- Planned & executed various events, including an annual conference with 12 educational tracks for 200+ attendees.Responsibilities:• Oversight of the ISO 9001 compliant QMS & employee recognition programs for AWS Headquarters.• Developed & implemented new programs, systems & training designed to improve service to members, customers & staff.• Served as AWS Headquarters Management Representative, with responsibility & authority to establish, implement & maintain the QMS.• Served on the AWS Management Review Team.• Coordinated the scheduling of & conducted internal audits of QMS work processes & served as Lead Auditor.• Assisted business units in meeting criteria of 3rd-party certification/accreditation programs.• Maintained contents of the Administration business unit Operations Manual.• Participated in activities contributing to continuous improvement & support of a quality culture.