-Developed and implemented a comprehensive quality assurance strategy to ensure Customer Experience (CX) teams (7) meet quality goals-Established and enforced QA/QC processes and procedures: quality standards, document control SOPs/WIs, change management, auditing processes-Developed a team of 30 quality assurance professionals : hiring, 1 : 1 performance reviews, mentoring, and training to ensure their success and professional development-Collaborated with cross-functional teams, including product development, engineering, supply chain, and sales, to drive continuous improvement and process implementations : AI initiatives for customer inquiries, reduction in touch points in the customer journey; Salesforce, customer satisfaction, employee satisfaction process-Further developed KPIs for each team based on data-driven examination, VOC and Industry StandardsOptimization of teams : Quality Auditing (Smartsheets), Document Control (Salesforce), Knowledge Library, Career Laddering, Training (LMS), and Workforce Management (Calabrio)

-Provided strategic leadership and management in development of the Customer Support Quality Dept with the addition of roles such as Training, Knowledge Library, Onboarding, and Quality Process Leaders-Educated and drove quality practices and standards across the business : Kaizen, SOPs, Change Management-Expanded quality auditing to each team within Customer Support with a goal of 90% accuracy-Developed and implemented quality calibration programs for QC auditors and Team Managers-Developed and implemented an onboarding program for all roles within Customer Support

- Lead ISO 9001:2015 Audit program for NA sites (6): develop qualified auditors, develop audit schedule and monitor for timeliness of audit completion, review audit report content, trend/analyze audit findings - Lead supplier development program for NA sites: develop supplier audit schedule for the year, train/develop SQE's to perform qualification audits, review audit reports for content, ensure follow-up/closure of audit findings, implement monthly supplier reporting to SC sites.- Continuous improvement projects leader: $5M overdue product – drive reduction of overdues and increase RDD %- Continue improvement project leader: HR processes – define/implement structure for HR processes, reduce onboarding timeline for hourly employees (reduced from 4 wks to 4 days)- Continuous improvement project leader: Part set-up – reduction of ~10k part errors by identifying error root cause, process improvement opportunities, and resolution actions- North America quality leader for key customer issue resolution driving issue resolution and root cause analysis, as well as overall supplier score improvement. - Lead monthly quality rhythms and analysis for KPIs – Customer issue resolution, Top Quality issues, Case resolution- Lead Quality University training sessions for NAM QLs- Mentor ABB teams on process definition, analysis, root cause analysis, action implementation- North America Hub quality leader focused on leading efforts of 2 plants for establishing an ISO 9001 quality management system – certifications obtained.- Customer issue resolution leader for escalated customer issues resulting in RCs, corrective action, and customer satisfaction. Resolved cases ranging from $200k – 1 mil.- Implementation of software programs and associated process, including development of documentation, training, and monitored maintenance.

- Development and implementation of an ISO 9001:2008 certified Quality System. Ensured repeated certification through yearly surveillance audits.- Customer interface for issue resolution: Risk assessment, Root cause analysis, corrective/preventive actions. 100% increased customer satisfaction with 3 largest customers.- Weekly and monthly metric analysis. Identified trends and actions needed based on the trends. - Ensure daily quality of products through documentation and visual inspections to ensure minimal external defects. - Collaborate with vendors to improve quality of products through weekly reviews, drawing reviews and improvement plans.

- Led a cross-functional team to process map the ITO/OTR flow and identified opportunity improvement areas: system standardization, digitizing records, eliminating duplicate toll-gates. - Reduced order processing costs saving $100K per year

-Provided leadership and quality guidance to the facility as well as MR modality quality projects.-Maintained CAPA system by evaluating Impact Assessments, Root Cause Analysis, Investigation and Action Plan activities and completing Effectiveness Checks.-Facilitated Bi-Monthly CAPA Review Boards reviewing open findings, trends of all CAPA inputs, and identified and resolved systemic issues requiring CAPA.-Developed QMR materials and conduct follow-ups for closure of action items.-Interfaced with FDA, ISO (9001 and 13485), and MDD auditing agencies.-Issued concessions and product holds as needed when acting for Site QA Manager.

-Quality Rep of the cross functional core team for new product introduction (NPI); working with Engineering on all aspects of Design Controls Milestones – Inputs, Outputs, Design Reviews, Verification, Design Transfer.-Leader for validation activities of new product introductions, software, equipment, and processes.-Interfaced with FDA, ISO (9001 and 13485), and MDD auditing agencies.

•Develop and implement an internal audit team by establishing an audit schedule, developing procedures, checklists and report templates, training personnel from all functions in audit techniques and guidelines and ensure the audits are conducted per the schedule. Lead internal audits.•Implement an electronic DHR software system by managing phases of the project and validating the system/software and maintaining its quality integrity through training session and procedure modifications. Validation package was later used for global implementation.•Ensure regulatory compliance and optimization of the QMS through development, maintenance and improvement of documented processes.•Provide training on newly implemented or revisions of Quality Management System procedures.•Manage software, process and process equipment validations for manufacturing and design controls for NPIs.•Develop and implement new processes, procedures and forms for software (CSV), process and process equipment validation.•Conduct root-cause analyses and resolution of CAPAs.•Quality representative for manufacturing regarding MRBs, Concessions and Eng Test Plans, Eng Change Requests and Orders.•Ensure compliance with and act as a quality representative for external and corporate audits such as FDA, UL, TUV and QMS audits