Danaher Corporation Quality Assurance Director in Charlotte, North Carolina
Danaher Company Description
KaVo Kerr is a cohesive organization comprised of two global leaders, united to provide dental excellence and serve as a single premier partner for the dental community. KaVo Kerr operates with a common vision inspiring and helping our customers, their patients and our own associates realize their potential. KaVo Kerr offers solutions for endodontics, restoratives, treatment units, infection prevention, imaging, rotary and instruments
MAJOR RESPONSIBILITIES: * Ensure that the site’s products comply with all applicable Worldwide Regulations and Global Standards. * Act in the capacity as the site’s Management Representative, responsible for the maintenance, performance, and improvement of the site’s Quality System. * Preparation, performance, and follow-up, for the site, through all 3rd party audits and inspections. * Lead, grow, and develop the local QA organization, consisting of Quality Systems, Quality Operations, and Technical Quality segments, providing sound guidance to drive and improve the performance of individual contributors, while continuing to improve the overall performance of the team. * Collect & analyze data, at prescribed intervals, and generate reports to drive quality improvement, cost reductions, product and process improvements, and to maintain compliance with internal procedures and external regulations and standards. * Partner with functional leaders (Operations, Engineering, Purchasing, etc..) to optimize quality management system processes that ensure compliance, drive simplification, and enhances product quality. * Partner with, and advise, all functions and management on quality requirements. * Work with project teams, and colleagues involved with the development of new products, on meeting quality requirements, and assisting engineering, or other functional groups, in the design and development process. * Proactively improve product quality, and site compliance, through the use of the tools and science of Quality. * Lead quality and continuous improvement efforts across the site by utilizing trend data and the CAPA process. * Oversee the site’s internal audit and supplier improvement programs. * Lead the implementation of DBS within QA. * Performs other duties and tasks as assigned.
Minimum Requirements: * Bachelor’s Degree is required * 10 years of experience in Quality Assurance/Quality Control with relevant Quality Management System and compliance experience. * 5 years of experience within the Medical Device industry with proven experience in Quality System Management following Worldwide Regulations and Standards.
Preferred Requirements: * Master degree * Proficient in the use of a computer, MSOffice suite knowledge/experience required * Experience performing the duties of the Site Management Representative. * Proven experience in implementing quality systems in a Medical Device regulated environment * Past experience in leading continuous improvement efforts, in both quality systems and products * Experience with root cause analyses, DOE’s, statistical methods, Kaizen’s, lean manufacturing, and Six Sigma. * Experience with, and practical understanding of, the use of continuous improvement tools including Transactional Process Improvement and Standard Work methodologies. * Black belt certification * Project management skills – Experience leading projects and managing sustainment * Experience in the strategic planning of quality/compliance processes and objectives * Track record for successfully driving multi-faceted cross functional projects * Experience in leading complex organizations to high levels of compliance
Kavo Dental Technologies LLC is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing. #LI-PB1 IND-KAVO
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and industrial solutions. Our globally diverse team of 59,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #144 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Organization: KaVo Kerr
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-NC-Charlotte
Req ID: KAV002438