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
This position will be responsible for a number of Quality Engineering functions within the Imaging business, primarily identifying and driving the resolution of internal and external quality issues. This will be done through the CAPA process and direct interaction with Operations, Marketing, Sales Support, and Engineering on technical issues and solutions, direct technical support of forward model engineering projects and approval of engineering documentation, process and hardware verification/validation, supplier quality and systemic improvements to the Quality Management System. This position will also be responsible for the review/approval of supplier data associated with product and specification changes.
Essential Duties and Responsibilities: * Identify and drive the resolution of internal and external quality issues. * Manage the CAPA process and drive CAPA’s to implement countermeasures for product and process issues. * Provide technical and quality system support for forward model projects, including hardware and software. * Work with suppliers to improve and sustain quality improvements. * Routinely compile and report key quality metrics data to multiple organizational levels. * Serve as lead resource for Production Part Approval Process (PPAP). * Conduct technical investigations in support of the MDR process. * Lead routine Material Review Board (MRB) meetings to identify supplier quality issues and ensure timely disposition of nonconforming materials. * Maintain accuracy of calibration records and calibration schedule. * Arrange and coordinate calibrations by external Calibration Services providers to maintain 100% compliance to schedule with no past-due calibrations. * Lead Internal Audits of the QMS. * Execute process improvements as they relate to quality system compliance with ISO/GMP requirements. * Other duties as assigned. * Daily, weekly and monthly monitoring of internal defects by PPM measurements. * Improved internal and external PPM. * Continuous improvement of the QMS, ISO, and GMP systems.
Minimum Qualifications: * BS in Engineering or similar discipline, preferably Electrical or Mechanical Engineering. * 3 to 5 years of Quality Engineering experience, preferably in a medical device manufacturing environment or other regulated industry. * 2 years of experience in successfully working within ISO/FDA compliant Quality Management Systems and supplier quality programs. * Working knowledge of Process Controls and Design Controls within a regulated Quality Management System (CFR 820), and applicable knowledge of Risk Management and Supplier Quality is required * Experience Microsoft Office * Strong Excel skills
Preferred Qualifications: * Successful track record of driving continuous improvement in both quality and compliance. * Exposure to FDA/ISO regulations. * 3-5 years of experience in role requiring root cause analysis, DOE, Statistics, Lean Manufacturing, and Six Sigma. * Experience in implementing QS/ISO quality systems as related to the automotive or medical device industry. * Past experience in Operations and/or Design Engineering. * Familiarity with electrical medical device manufacturing and the Toyota production business model. Experience with root cause analysis, DOE, statistics, lean manufacturing, trending, Risk Management, and Six Sigma methodologies. * Experience with statistical software packages (preferably Minitab). * Ability to adapt and work effectively in a fast-paced environment of change, uncertainty, and ambiguity, while making timely decisions. * A bias for taking action – spontaneous recognition of problems and opportunities.
Dental Imaging Technologies Corporation 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.
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 $16.5B in revenue last year. We are ranked #133 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.
Quality and Regulatory Affairs
North America-North America-United States-PA-Hatfield
Danaher Corporation Jobs
Website : http://www.danaher.com
Microscopes that let researchers see life at 100 nanometers in three dimensions. Dental diagnostics that spot decay as it forms, enabling painless, noninvasive treatments. Disinfection technologies that help ensure safe drinking water at the rate of billions of gallons of water a day. Transaction systems that bring new levels of speed and security to consumers. Network analyzers that link seamlessly with sophisticated software to maximize uptime. Danaher products span some of the most demanding applications in the world, creating new possibilities not only for those who use them, but for millions more who never give them a moment’s thought. In every case, they’re delivering benefits that matter to markets that are eager for innovation. And we are doing it through a customer-centric approach that unites our businesses and has made them global leaders.