Quality Transformation Project Lead

Company: Kimberly-Clark
Location: Beech Island
Posted on: November 19, 2021

Job Description:

Quality Transformation Project LeadJob DescriptionDriving initiatives across Quality, Regulatory Affairs, Product Safety, R&E and Operations/Supply Chain

• Responsible for defining, resourcing, and leading multiple workstreams as part of the Quality Transformation.--- Develop transformational objectives and keep the team organized to achieve target milestones.--- Develop and implement QMS processes and policies that drive a Quality culture
  • Provide insight and understanding on current K-C Quality Systems, ISO, and industry quality standards.
    • Works with other stakeholders to define, prioritize, and develop quality focused projects and programDrive opportunities to standardize, apply continuous improvement, and reduce complexity where possible
      • Accountable for monitoring progress, removing roadblocks, escalating issues
        • Collaborative support and communication with Product System and site management.
          • Lead with a Continuous Improvement mindset using LEAN and OPEX thinking/tools
            • Positive work environment maintained to promote talent development, coaching, and employee relations
              • Demonstrated capability associated with the One KC Behaviors.Experience in Regulatory affairs, Regulatory Compliance, familiarity with Regulatory Agencies such as the FDA
                • Knowledge of Medical Device regulations and supporting quality system elements. Included but not limited to Process Validation, CAPA, Design Controls, Risk Management and Post-Market Surveillance.
                  • Exceptional ability to manage without direct authority at all levels of the organizationTECHNICAL KNOWLEDGE AND SKILLS:--- Corporate and mill policies and procedures--- Safety policies and regulations
                    • Quality Management System (QMS)requirements
                      • Good Manufacturing Practices (GMP) requirements
                        • Product Specifications and Requirements
                          • Internal control and External Audit procedures--- Supply chain knowledge--- Process knowledge/capabilities---Product/raw material knowledgeQUALIFICATIONS/EDUCATION/REQUIREMENTS
                            • Bachelor's degree from an ABET accredited institution in Business, Engineering, Science, or related field
                              • Minimum of 7+ years of experience in a high-speed industrial manufacturing environment
                                • Experience in quality, technical, or related roles with a demonstrated record of achievement and leadershipPreferred Qualifications:
                                  • 10+ years of experience in a high-speed industrial manufacturing environmentExperience in Regulatory affairs, Regulatory Compliance, familiarity with Regulatory Agencies such as the FDA
                                    • Knowledge of Medical Device regulations and supporting quality system elements. Included but not limited to Process Validation, CAPA, Design Controls, Risk Management and Post-Market Surveillance.
                                      • Exceptional ability to manage without direct authority at all levels of the organizationGlobal VISA and Relocation Specifications:Primary LocationUSA-SC-Beech IslandAdditional LocationsWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Kimberly-Clark, Augusta , Quality Transformation Project Lead, Other , Beech Island, Georgia