Danaher Corporation CAPA Specialist 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.
POSITION SUMMARY : The CAPA Specialist is r esponsible for the management of the site Corrective Action and Preventive Action (CAPA) program. Activities include ensuring compliance to process requirements; helping to lead root cause analysis activities; demonstrating leadership in organizing and driving solutions based teams; and serving as the resident expert in CAPA regulatory/compliance.
Essential Duties and Responsibilities:
- Responsible for the management and overall effectiveness of the Corrective and Preventive Actions (CAPA) process
- Provide high level management of the CAPA process to contribute to the continuous improvement strategy of the Quality Management System (QMS)
- Develop and manage CAPA operational processes
- Administrative duties include but are not limited to the monitoring of information relative to problem statements, root cause analysis, corrections, corrective and preventative actions, tracking of time lines, and establishing CAPA files
- Serve as a resident expert in CAPA regulatory/compliance
- Monitor the effectiveness of the CAPA system and implement continuous improvement as needed
- Coordinate all needed training for users of the CAPA system
- Serve as the coordinator of the CAPA meetings
- Trend CAPA metrics and present defined reports at specified intervals
- Present CAPA information during Management Reviews
- Assist/Interface with CAPA owners on CAPA Investigations and Action Plans
- Partner across sites to harmonize Quality processes
- Bachelor’s Degree required
- 5 years of experience in Quality Assurance setting required
- 1-2 years minimum of CAPA experience required
Working knowledge of worldwide quality system regulations required.
Demonstrated ability to conduct in-depth root cause analyses, develop thorough corrective action plans, and determine the effectiveness of implemented actions
- A Bachelor's degree in Engineering, Life Sciences, Technical or Business preferred
- 10 years of experience in Quality Assurance setting
- Attention to detail when reviewing documentation and completing auditing activities
- Innovative with the ability to make sound suggestions for improvement
- Highly compliance oriented to firmly adhere to principles of regulation and standards
- Experience in a Medical Device Quality Assurance setting, familiar with FDA regulations and/or ISO standards
Possess effective presentation and writing skills.
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-NC-Charlotte
Req ID: KAV003565