Scott Weber

About Scott Weber

Results-driven, dynamic leader with QA/RA business mindset, practical perspective, and technical, managerial, and executive experiences. Key leadership team member and stakeholder, directing customer-facing programs at highest levels, meeting proactive (business development) and reactive (issue resolution) achievements. Cultivates high-performing teams, working from OEM and contract manufacturing viewpoints and balancing business goals with client needs for mutual success.Proven background directing quality assurance, regulatory affairs, and engineering functions within global companies, participating in multiple industry sectors. Breadth of exposure to various manufacturing operations, including medical devices, pharma, paper/plastic converting, plastic extrusion and molding, and complex electronics.Quality Management Systems (QMS)| Quality Control & Assurance | Organizational ManagementRegulatory Affairs & Compliance (US FDA / International)| Sterilization | Plant EngineeringEquipment & Product Design | OEM & Contract Manufacturing | Collaborative Leadership

Experience

1. Vice President of Quality

   Pacur

   Oct 2023 — Present · Oshkosh, WI, US

   Responsible for executing and improving the Pacur/Carolex global quality strategy. Provide leadership to the entire quality control, quality assurance, and regulatory compliance functions to ensure the company meets customers’ and regulatory requirements. Accountable to lead a quality-centric culture throughout the Pacur and Carolex operations.

Education

• Milwaukee School of Engineering

  Master's of Science, Engineering Management (MSEM)

  1993 — 1998

• Michigan Technological University

  Bachelor's of Science, Mechanical Engineering (BSME)

  1984 — 1988

Skills

• Auditing
• Quality System
• Quality Systems
• Process Capability
• Manufacturing Operations
• Document Management
• Value Stream Mapping
• Process Improvement
• Failure Mode and Effects Analysis (Fmea)
• Validation
• Spc
• Quality Assurance
• Iso Standards
• Medical Devices
• Capa
• Iso 9000
• Continuous Improvement
• Compliance
• Quality Management
• Iso
• Business Process Improvement
• Fda
• Manufacturing Operations Management
• Fmea
• Product Quality
• Iso 13485
• Root Cause Analysis
• Kaizen
• Quality Engineering
• Dmaic
• Operational Excellence
• Manufacturing Engineering
• Design of Experiments
• Manufacturing
• Contract Manufacturing
• Corrective and Preventive Action (Capa)
• Apqp
• Cross-Functional Team Leadership
• Supplier Quality
• Product Development