Scott Soukup Email & Phone Number

Lake Villa, Il, Us

Quality System Specialist (October 2017 – present) - Printing Operations• Quality system remediation for ISO 9001:2015CAPA Specialist (February 2017 – August 2017) - Aseptic Filling and Drug Compounding Operation• Completed CAPA investigations for 30 various Aseptic filling and compounding issues to determine root cause and develop corrective action plans•Created a CAPA process/procedure to simplify the process and to include risk for determining CAPA eligibility•Created… Show more Quality System Specialist (October 2017 – present) - Printing Operations• Quality system remediation for ISO 9001:2015CAPA Specialist (February 2017 – August 2017) - Aseptic Filling and Drug Compounding Operation• Completed CAPA investigations for 30 various Aseptic filling and compounding issues to determine root cause and develop corrective action plans•Created a CAPA process/procedure to simplify the process and to include risk for determining CAPA eligibility•Created training material explaining the process from nonconformance to a CAPAQuality System Specialist (2015 – 2016) - Printing Operations • Developed internal auditing training material used to train internal authors at two sites• Mentored internal auditors in conducting effective audits• Developed a method to evaluate CAPA’s used to track improvement of CAPA implementationCAPA Specialist (2014 – 2015) – Wound Care Operations•Owner of several systemic quality systems CAPA’s with the responsibility of determining the root cause and implementing corrective action. All assigned CAPA’s corrective action were implemented per plan.• Review previous closed CAPA’s to determine compliance of the CAPA to current requirements and re-execute as needed. All of assigned CAPA’s were reviewed and re-executed as needed.CAPA Program Manager (2010 – 2014) – Reagent and Test Equipment Manufacturer•Reduced CAPA open time from an average of 360 days to 150 days by implementing regular status meetings and accountability bulletin boards•Implemented resolutions for 52 high-risk product safety issues. Majority of the resolutions included filed actions, field modifications and/or product redevelopment actions•Improved the CAPA system such that 235 issues were reduced to 19 in one year’s time. Established eligibility criteria which reduced the rate of new CAPA’s by 60%•Created CAPA procedure and work instruction to improve consistency for CAPA documentation•Mentored CAPA owners on the improved CAPA process Show less

Directed a global cross functional team to strengthen and improve the quality management system by implementing revised ISO 9001 quality management system standard. Managed the relationship with the certification company to complete the annual certification process. - Achieved ISO9001:2008 certification at 24 facilities with a 66% reduction in staff by leading a team of quality system professionals to combine seven quality manuals into one and reduced 36 key processes to six. -… Show more Directed a global cross functional team to strengthen and improve the quality management system by implementing revised ISO 9001 quality management system standard. Managed the relationship with the certification company to complete the annual certification process. - Achieved ISO9001:2008 certification at 24 facilities with a 66% reduction in staff by leading a team of quality system professionals to combine seven quality manuals into one and reduced 36 key processes to six. - Lowered ISO certification cost by12% through negotiating with the certification company to conduct site audits instead of department audits, reducing the number audit days from 25 to 20 days. Show less

Directed quality system leaders at 11 design centers and one manufacturing facility to continuously improve their quality management systems. Responsible for conducting internal audits for the design headquarters. - Incorporated the significant changes to the ISO 9001 standards by leading a team of quality system leaders to create a quality manual and the required procedures. All design centers and the manufacturing site achieved ISO 9001:2000 certification on schedule with no major… Show more Directed quality system leaders at 11 design centers and one manufacturing facility to continuously improve their quality management systems. Responsible for conducting internal audits for the design headquarters. - Incorporated the significant changes to the ISO 9001 standards by leading a team of quality system leaders to create a quality manual and the required procedures. All design centers and the manufacturing site achieved ISO 9001:2000 certification on schedule with no major nonconformance.- Led a team of quality professionals to create an internal activity-based auditing class to replace an external class saving approximately $100,000. - Obtained Green Belt certification by implementing a companywide documentation system to replace the current restricted system. Implemented the system one month ahead of schedule by leading a team of documentation specialists. - Mentored the quality system leader at the Chihuahua, Mexico cellular phone manufacturer site to achieve TL 3.0 quality system certification on schedule by training an on-site implementation team. Ensured on-time certification by conducting regular meetings with the quality system leader.- Reduced the number of repeat audit findings by approximately 45% by developing an audit governance process for 13 facilities. Show less

Managed the quality management system for the design headquarters and a manufacturing site. Accountable for a staff of four to plan and conduct internal audits and follow-up on corrective actions. - Achieved ISO 9001:1994 quality management system certification on schedule by training a cross functional team on the ISO requirements. Led the team in implementing an internal audit process and corrective action system.- Reduced costs by $75,000 by eliminating the need for onsite… Show more Managed the quality management system for the design headquarters and a manufacturing site. Accountable for a staff of four to plan and conduct internal audits and follow-up on corrective actions. - Achieved ISO 9001:1994 quality management system certification on schedule by training a cross functional team on the ISO requirements. Led the team in implementing an internal audit process and corrective action system.- Reduced costs by $75,000 by eliminating the need for onsite quality system consultants. Replaced the consultants with available internal resources by developing and leading a quality system improvement team. Show less

Managed plant quality operations and customer and supplier relationships for a battery pack manufacturer. Managed a group of 6 supervisors, quality engineers and technicians responsible for the daily quality assurance activities. - Improved quality indicators by 80% by establishing a new quality system. The system included a method for writing clear procedures, a defect tracking system and a correction action system. - Reduced customer complaints by 85% by establishing one point… Show more Managed plant quality operations and customer and supplier relationships for a battery pack manufacturer. Managed a group of 6 supervisors, quality engineers and technicians responsible for the daily quality assurance activities. - Improved quality indicators by 80% by establishing a new quality system. The system included a method for writing clear procedures, a defect tracking system and a correction action system. - Reduced customer complaints by 85% by establishing one point of contact for customers and creating a customer complaint corrective action system.- Improved supplier performance 40% by leading a team consisting of two key suppliers, site engineering manager and production manager to create a supplier improvement system. Show less

Held various roles of increasing responsibility in the manufacturing of medical devices. Positions held include: IV solutions set supervisor, extrusion supervisor, quality supervisor and quality superintendent for injecting molding assessment manager group quality manager for reusable sterile surgical gowns.

Mba, Business

Bs, Marketing