Danaher Corporation Quality Assurance Engineer in Hatfield, Pennsylvania
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.
The Quality Assurance Engineer is responsible for a number of quality engineering functions, including design, manufacturing, sustaining, and supplier quality engineering, primarily identifying and driving the resolution of internal and external quality issues. This is done through using internal Quality System processes, following external regulatory standards and regulations, and through direct interaction with internal functions on technical issues and solutions. They will also be responsible for direct technical support of forward model engineering projects, the creation, review, and approval of engineering documentation, process and hardware verification/validation support, supplier quality activities, and the implementation of systemic improvements to the Quality Management System.
Essential Duties and Responsibilities:
- Identify and drive the resolution of internal and external quality issues through ownership and use of the site risk processes
- Own and drive CAPA projects to completion, to eliminate, or greatly reduce the cause(s) of product quality issues and process compliance issues
- Provide hands on technical and quality system support for new product introduction (NPI), projects, including hardware and software products
- Monitor supplier performance through the supplier management program. Where necessary, work with suppliers to improve and sustain quality improvements
- Qualify new suppliers and continually evaluate existing suppliers
- 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
- Support Material Review Board (MRB) meetings to identify supplier quality issues and ensure timely disposition of nonconforming materials
- Support Manufacturing Operations in efforts to drive process improvement and on time delivery
- Lead internal audits of the QMS, as part of the Internal Audit Team
- Other duties as assigned
- BS in Engineering or similar discipline, preferably Electrical or Mechanical Engineering
- 5 years of quality engineering experience
- 3 years of experience in a medical device design and/or manufacturing environment or other regulated industry
- 1 years of experience in root cause analysis and implementing sustainable processes
- 2 years of experience in 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.
- Successful track record of driving continuous improvement in both quality and compliance.
Proficient with statistical software packages (preferably Minitab), as well as Microsoft Office.
Experience in Operations and/or Design Engineering highly desired.
- Familiarity with electrical medical device manufacturing and the Toyota production business model helpful, but not required
- Experience with root cause analysis, DOE, statistics, lean manufacturing, trending, Risk Management, and Six Sigma methodologies
1 years’ experience managing/leading projects
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
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-PA-Hatfield
Req ID: KAV002963