Dominique Rodriguez

Responsible for providing technical quality support, including inspecting materials, processing and product testing, maintaining the QMS , facilitate internal and external audits, investigate nonconformities, and complete corrective actions. Provide support to Production and Engineering teams. • Update and edit manufacturing work instructions, drawings, and SOPs. • Write Engineering Change Orders, CAPAs, and other quality documentation. • Facilitate internal and external audits to meet regulatory standards. • Collaborate with Engineering and Production on various projects. • Review and investigate product complaints for all products. Test, troubleshoot, and repair devices, including experience with PCBA components. • Assist Test and Service technicians with troubleshooting. • Building test fixtures, tooling, and other items to assist with manufacturing of products. • Assemble projects as directed by Engineering and Production teams. • Run Validation and Verification testing, as required.

• Responsible for reviewing and investigating product complaints for all medical products. • Responsible for determining and filing any required Medical Device Reports (MDRs) with the FDA. • (ISO 13485) • Process and provide data on trending for all non-conformance reports. • Responsible for control, filing, retrieval, and maintenance of master and reference documents, electronic and hard-copy archival system for controlled documents. • Manage document changes and approvals. • Support the development of QA (QMS) systems, directives, and SOP's. • Quality Operations and Quality Engineering, supporting products/processes and quality system maintenance and development. • Initiate, manage, and investigate Corrective and Preventative Actions(CAPA) as appropriate. • Ensure all quality records are kept in an organized and easy to retrieve manner. • Maintain records with the device DHF (Design History Files). • Perform internal audits. • Assist in regulatory audits(FDA/ISO) and investigations. • Work closely with production and other various service departments. • Responsible for company-wide training for new documents and revisions. • Organize standards and maintain current version of standards. • Support regulatory filings - assembly of submissions and electronic and FedEx shipment to FDA and other regulators.

Trainer for all QC associates. Ensure the quality inspection of all medical devices. Proficiency in GDP throughout all documents. Responsible for all inspection of parts/materials received for use in production. Experienced in using instruments such as calipers, gages and multimeters. Closely worked with production and shipping departments to ensure quality standards. Maintain detailed records of medical device inspections and Non-Conformance reports. Arranged and inspected a CM build with up to 60,000 parts before sending to manufacturer.

• Customer Service: Providing excellent customer service, ensuring a welcoming environment, and addressing passenger requests professionally. • Safety and Security: Performing pre-flight safety checks, demonstrating safety equipment, and ensuring passenger compliance with safety regulations. • In-flight Services: Serving beverages, meals, and snacks, and attending to passenger needs throughout the flight. • Emergency Procedures: Handling in-flight emergencies, administering first aid, and coordinating evacuations if necessary. • Sales and Marketing: Potentially marketing and selling products during flights. • Maintaining Order: Ensuring the safety and comfort of passengers by maintaining order on the plane. • Boarding and Deplaning: Assisting passengers during boarding and deplaning procedures.

Answered quality tickets by investigating the issue thoroughly and taking pictures of the products for the vendor. Problem solve PO’s with unidentified origins and simplify processes for inbound problem solvers. Damage/liquify items safely to adhere to regulatory standards. Aided Problem Solve team with defects and questions about quality throughout the warehouse.

Assisting the Area Manager and ensuring the smooth operation of the packing and shipping process. This involves a combination of production duties, process management, and associate support. Key responsibilities included picking and packing orders, receiving and stowing inventory, maintaining inventory accuracy, and unloading/loading trucks.Training associates, ensuring compliance with standard operating procedures (SOPs), and contributing to a safe and efficient work environment.