Eric Edstrom Email & Phone Number

Reading, Pennsylvania Area

Develop, implement and maintain an ISO 9001-2015 compliant Quality Management System. Manage CAPA, NCMR and Risk Assessment systems, including root cause analysis and verification of corrective actions.Team Lead for process improvement initiatives to optimize material flow based on value stream analysis.Team lead for all PPAP and Quality Planning activities, including PFMEA and Control Plans.Performance reporting based on statistical analysis.Trained all personnel on QMS procedures and work instructions.Managed QC measurement equipment and calibration.Chairman of state certified Safety Committee, including performing monthly safety audits and tracking and reporting safety issues and activies to management. Coordinated with HR to perform accident investigations, coordinated with an external consultant to provide safety training as required. Maintain OSHA compliance throughout the facility, including PPE assessments, SDS, etc.

Managed direct reports supporting R & D projects and wireless technologies R & D labs across 4 facilities in the US and Canada. Supported projects ranged from small innovation projects to technology development projects with multiyear lifecycles. Served as R & D liaison to the Finance department. Member of the Corporate Budgeting and Forecast team. Member of the Corporate Process Automation team. Team Lead for several workflow development and implementation efforts, resulting in improvements in process performance and reliability, and yielding significant cost reductions. Received company sponsored Innovation Award for Workflow Development and Process Automation.Provided oversight of Engineering purchasing activities and related processes including software tools, engineering services contractors and on-site and offshore resources. Reduced coding issues and improved the accuracy of financial performance tracking data. Monthly reviews and reports of R & D Purchasing activities helped ensure compliance with SOX requirements. Administrative oversight of 3 R & D Offshore Development Centers and up to 20 on-site consultants and contractors.

King Of Prussia, Pennsylvania

Managed direct reports and contractors supporting internal technology development projects and several large multi-year projects with global partners/customers, including the US Military. Tracked and reported projects financial and schedule performance. Liaison to Customers/Partners/Vendors for R & D project deliverables. Managed a process for making electronic deliveries to external entities with controls designed to mitigate risk and ensure security of IP. Continued to refine and improve the process in conjunction with the Quality Management Team. Administrative oversight of 2 R & D Offshore Development Centers and up to 30 R & D on-site consultants and contractors. As liaison to the Corporate Quality Department participated in the development, maintenance, and internal auditing of Engineering and Corporate Quality processes and procedures.

King Of Prussia, Pennsylvania

Managed direct reports and contractors supporting internal technology development projects and several large multi-year projects with global partners/customers, including the US Military. Tracked and reported projects financial and schedule performance. Liaison to Customers/Partners/Vendors for R & D project deliverables. Developed and managed a process for making electronic deliveries to external entities with controls designed to mitigate risk and ensure security of IP. As liaison to the Corporate Quality Department participated in the development, maintenance, and internal auditing of Engineering and Corporate Quality processes and procedures.

King Of Prussia, Pennsylvania

Managed direct reports and contractors supplying CAD and Documentation Control services to the Engineering and Operations staff. Managed Wireless Telecommunications R & D lab, including facilities, hardware, test equipment, and other resources. Managed the conversion of all historic paper technical documentation to electronic .pdf files by contracted vendor.Member of the ISO Quality Team, performing internal audits and vendor qualifications of prototype manufacturing contractors. Co-Chairman of Corporate Safety Committee, obtained Pennsylvania State Safety Certification, reducing insurance costs. Conducted a pilot project in conjunction with Product Testing Dept. to demonstrate the potential ROI of portable automated test systems. Reported initial cost savings of approximately 30% against the existing methodology.

Montgomeryville, Pa

Managed 3 direct reports performing QA/QC functions across all phases of the manufacturing process, from incoming parts inspection to final testing of product prior to packaging in compliance with GMP and FDA requirements.Coordinated with vendors on product sterilization and verification testing of sterilized product.Was responsible for operation and maintenance of Class 10000 clean room. Coordinated with vendor for verification testing and certification.Performed failure analysis of mfg rejected and customer returned product.Performed tracking, analysis, and reporting of QA/QC data.Assisted Director of Quality with FDA and ISO Registrar audits.Team Lead for process improvement initiative.

Electronics Technology

Small Business Startup And Operations