Conducts first article, receiving, in-process, and final inspections to ensure component and raw material compliance with specifications.Performs mechanical and dimensional inspections using calibrated equipment to maintain quality control standards.Manage and collaborate in non-conforming materials system management and supplier qualification activities.Assists with GMP QA auditing and vendor qualification for component and manufacturing operations and lot history records to support product release for clinical trial and commercial distribution.Developed and implemented systems for inventory and material flow management, achieving seamless production support.Maintained 100% compliance with quality and regulatory standards, ensuring zero audit findings.Spearheaded training initiatives, improving team proficiency in inspection procedures.Critical role in obtaining FDA approval for mechanical/drug application device.Participates in cross-functional teams, providing feedback and support.Supports change control processes including writting quality inspection techniques to ensure clarification and consistency in GMP.Maintains up-to-date knowledge of the GMP QA landscape, regulations, and Quality System requirements (e.g., Standard Operating Procedures, Work Instructions) to support and maintain World Class Processes.Collaboratively participated in efforts with Product Developement Engineering, Manufacturing Engineering, and Quality Engineering to design, develop,, test and implement processes, tooling, and fixtures for Quality Inspection and actively participates in product/process engineering problem resolution and improvement projects.Works closely with the company's Engineering/Production Design, Manufacturing and Regulatory teams.

Pajama Program is a non-profit organization providing sleepwear and books to kids in need. Manage the region's funds raising events, community pajama drives, public relations, indentifying and screening receiving organizations, reporting and chapter communication.

Managed a team flexing in size from 40 to 70 outbound operators interfacing with the other managers of other departments ensuring an efficient operation and maximum utilization of available human and material resources. Maintained a high level of employee morale and integrity through positive motivation, development and training. Maintained performance reports including internal and external quality, and weekly and monthly shift productivity. Identified ways to reduce costs while improving efficiencies and quality including utilization of CPI processes.

Managed staff responsible for inventory movement of raw material from receiving to storage and from storage to issuance to Production. Responsible for supply and equipment acquisition. Maintained monthly inventory cycle-count process and yearly 100% physical inventory. Coordinated shipping and receiving processes utilizing contracted transporters and company-owned trucks within extreme time constraints.

Ensured the integrity of the Manufacturing Order System, the proper implementation of Engineering Change Notices, and the accuracy of the serial number tracking system. Supervised staff responsible for materials movement from front end operations, accurate and timely fulfillment of manufacturing orders and the issuance of completed orders to production.

Responsible for the development, implementation and administration of a coordinated support team which included; the purchasing function of supply and equipment acquisition, warehousing, receiving, distribution, inventory and other branch operational duties. Also provided administration of reports, budgets, utilization analysis, labor staffing, planning, and cost analysis.