Managed the research, development, installation, and implementation of a new electronic Quality Management System (eQMS) Software platform covering compliance to the ISO elements as well as other standards driving customer satisfaction to their requirements. In the first full year at Coining, drove customer complaints down 44% by installing new procedures and guidelines (before new eQMS). The second year, complaints were reduced a further 24% from the previous year. The third year, complaints were reduced a total of 90% in the past three years from 300 complaints a year in 2018 to 30 complaints in 2022. Updated 90% of all SOPs to bring the QMS into compliance. Used new eQMS software platform to establish standards with metrics for current and new processes to improve product quality and operational productivity. Developed the internal and external NCMR reporting process and integrated it into the eQMS platform for ease of reporting and follow through with the reporting dept. Managed the internal auditing program bringing Coining into compliance with regulatory standards and customer requirements. Developed metrics for Complaints, CAPA’s, NCMR's, PM, OTD, and RMA's.Set up processes for supplier performance, customer satisfaction, control of changes, rework, enhanced customer communication, equipment PM, counterfeit prevention process, and employee training matrices. Worked with OpEx to deliver an effective 5S program. ISO/Quality management representative. Manage and responsible for the daily activities of inspection personnel.Performing all PPAP, FAIR, Control Plan, PFMEA, Process Flowchart requests for Automotive and Aerospace customers.

Manage the projects and duties below as well as the added responsibility of managing the QAM and MAC processes (Quality Alignment Meeting / Market Action Committee) within the Critical Incident Management System by working with senior leadership, the manufacturing sites and TPO QA (Third Party Operations Quality Assurance) to obtain the required information such as Health Hazard Assessments (HHA) for each committee meeting to facilitate an informed decision regarding Recalls, etc. Plan and facilitate the meetings, gain committee approval, issue minutes, and track metrics. Developed workbooks to data mine statistics and best practices for determining the best course for process improvements and efficiencies. • PM Quality System Integrations of new company acquisitions (latest integration Activis/Allergan Sept. 2015-July 2016).• Reporting of quality KPIs and identify areas for improvement and work with sites to resolve discrepancies.• Work with sites in the region to ensure that all sites are reporting KPI’s consistently.

Added to the Quality Project Manager duties below are CAPA Manager (Corrective and Preventive Action). Manage the CAPA process; charged with bringing down the number of overdue CAPAs to 86% closed on time and process optimization. Regional Coordinator for Corporate Standards preview and gap analysis distribution, tracking and trending, and metrics reporting to management. Organize and manage all Quality Systems integrations and harmonization efforts. Regional Coordinator and process owner for Critical Quality Notifications to Management (NTM) and Global Notifications to Management (GNTM).

Assemble and manage cohesive project teams usually, but not limited to, from within the organization. Types of projects range from, site harmonization efforts, integration from acquisition, process improvement, efficiencies, cost savings, etc. Author project charters and submit for approval through the Steering Committee. When necessary, author process SOPs to be submitted for routing approval through Document Control. Develop "as is" and "end result" process flows as well as project risk plans for use in guidance of the team towards the end goal. Maintain a centralized "e" TeamRoom as a repository for all documentation that is generated as well as a project list for the entire QPM (Quality Project Management) team. When required by the project, prepare and submit for approval the project Completion Report. Prepare PowerPoint presentations for use as training guides at the conclusion of each project. Active in facilitating plant shutdowns, QC laboratory closings, documentation cataloging and archiving as well as revalidation of products and method transfers.

Develop and implement best practice concepts as well as perform internal special topics cGMP awareness training. Perform internal and external audits using both the departmental approach and systems approach (FDA Drug Manufacturing Inspection Program 7356.002) for continued regulatory compliance. Review Batch Records, Validation Reports, MDR, MIR, etc as necessary. Act as onsite FDA management representative. Write and distribute final audit reports that include discussion, observations found with recommendations (if any) and departmental responses to upper management. Responsible for Corrective and Preventive Actions (CAPA) follow up coming from internal and external audit observations as well as FDA 483 findings. Set up and lead internal cGMP facility surveillance tours.

Coordinate the reduction of potential product safety risks by developing an international product safety program. Develop product safety and quality systems policies, procedures and guidelines for both in-house and international manufacturing locations. Lead Quality Management Systems audits on the behalf of QA and Product Safety for factory certification purposes and for compliance to customer and Federal requirements / specifications. Travel internationally; training offices, field staff and factories on product safety procedures, testing criteria and analysis methods using statistical process control for zero defect safety issue policies. Assist factories with process qualification and validation. Work closely with the internal creative design teams and licensors to be proactive / preemptive in eliminating quality and product safety issues. Key brand licensors serviced are Nike and Levi's Youthwear.

(RF electronics and medical devices)Oversee implementation of Quality Agreements. Coordinate all Quality documentation interpretation, implementation and training. Direct all audits (internal/external) for continued certification. Implement ISO concepts and programs as well as cGMP’s, Batch Records review, Validation, DHR, DMR, etc. Key ISO & FDA management representative. Interface daily with all departments to identify, communicate and head-up quality improvement initiatives as well as customer satisfaction leading to exceptional performance as perceived by customers. Oversee all quality issues, root cause analysis investigations as well as product evaluation and testing. Recommend and initiate Corrective and Preventive Actions (CAPA). Administer Quality programs to ensure conformance to engineering and customer specifications and drawings. Review and approve DoD specifications and requirements.