Kent Schopp

About Kent Schopp

I am a highly accomplished executive known for my expertise in strategic planning…

Experience

1. Senior Director of Quality

   Kimberly-Clark

   Jun 2019 — Present · Neenah, WI, US

   Direct the daily quality operations of KCNA from product conceptualization and engineering to final distribution. Implement designcontrols, post-market surveillance processes, and strategic initiatives to empower the achievement of ambitious business objectives. Consult with executive leaders and global business partners to ensure the delivery of safe, effective products to consumers. Lead and manage the Quality division to develop and implement a comprehensive quality strategy. Ensure compliance with all quality standards, regulations, and certifications. Maintain quality metrics and reporting to measure and improve the effectiveness of the QMS.Proactively support an inclusive environment among leadership and promote diversity among the recruiting team and interviewees.Quality Management System (QMS) Development> Up-leveled and fully transformed KCNA’s QMS, resetting the requirements for high-risk (Class II medical device) products; planned an effective and pragmatic roadmap to upgrade the QMS by condensing and centralizing 3 separate systems into 1.> Owned responsibility for all elements of the KCNA quality system, including regulatory compliance with worldwide standards and regulations; aligned organizational goals and quality objectives to improve the efficiency and efficacy of the QMS.Quality Assurance Improvements> Created and implemented a design quality assurance team, a dedicated group partnering with R&E to bring concepts to life assigned the task of sustaining engineering after recruiting high-caliber talent capable of interfacing with the FDA; transformed a struggling report infrastructure by meeting FDA deadlines; created a successful program, resulting in prospective use on a global scale.

Education

• Southern Illinois University, Carbondale

  Bachelor's degree, Health/Health Care Administration/Management

  1994 — 1997

• Northwestern University

  Master's degree, Quality Assurance and Regulatory Science

  2010 — 2015

Skills

• Leadership
• Quality Control
• Quality Management
• Computer System Validation
• Lean Manufacturing
• Continuous Improvement
• 21 Cfr
• Root Cause Analysis
• 21 Cfr Part 11
• Standard Operating Procedure (Sop)
• Cross-Functional Team Leadership
• Supplier Quality
• Gxp
• Regulatory Affairs
• Fda Gmp
• Iso
• Sop
• Auditing
• Iso Standards
• U.s. Title 21 Cfr Part 11 Regulation
• Iso 9000
• Change Control
• Regulatory Requirements
• Quality Assurance