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
• Created training material explaining the process from nonconformance to a CAPAQuality System Specialist (2015 – 2016) - Printing Operations

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.

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.

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.

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.

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