Scott Mccormick Email & Phone Number

San Diego County, California, United States

San Diego County, California, United States

• Implemented a variety of Corrective and Preventive Actions (CAPA). Restructured medical record data collection and SOPs, resulting in complete elimination of data collection errors.
• Prepared software and hardware for manufacturing. Implemented improved hardware and software iterations.
• Deployed DICOM Product to Manufacturing and delivered product to customers to meet contractual obligations which represented large amount of revenue. Met delivery customer expectations on contractual delivery.
• Served as content expert on business systems and functioning to Manufacturing Engineering team and other cross functional members. Enabled team to come up to speed faster on new systems while maintaining manufacturing.

Greater San Diego Area

• Updated internal incoming hardware inspection process to ensure compliance with specifications in response to internal audit findings which resulted in improvement of the process and elimination of the non-conformance.
• Updated Device Master Record (DMR) process in response to Corrective and Preventative Action (CAPA). Enabled DMRs for a given product to be in a single source and aligned the structure with the Device History File (DHF).
• Deployed product software on new server and workstation operating systems which deployed new features and updates to increase customer satisfaction.
• Developed new process employing legacy systems for delivering newly licensed DICOM products to customers.
• Developed and implemented Process Validation process and executed IQ\OQ\PQ on Production Processes which enabled compliance with regulatory requirements and improve internal processes.
• Completed Project Management Training from IBM Internal University and applied knowledge to role as Manufacturing engineer.

San Diego, California, United States

• Relocated manufacturing function from California to Wisconsin with minimal downtown.
• Increased responsibility as the Manufacturing Engineer over multiple product lines which included assembly of optical manufactured assemblies from CAD drawings.
• Learned new systems (ERP and Document Control) and processes and adapted existing products to new company processes which speed up the ability to meet existing customer needs from the point of acquisition and transfer.

Greater San Diego Area

• Developed, implemented, and managed production process through continuous identification of areas requiring process improvement. Developed process and scripts to reduce build time from 55 minutes to 15 minutes.
• Member of core team that implemented new Agile PLM system to the organization going from a paper system to a digital system which improved process and quality across the organization.
• Member of core team which got initial ISO 13485 certification and provided support data-collection function during ISO 13485 audits over multiple years resulting in continued certification and supported FDA audit as.
• Managed multiple medical device software releases into manufacturing with associated documentation, Bills of Material (BOM), and parts to increase sales and customer satisfaction.

San Diego, CA

Greater San Diego Area

Greater San Diego Area