POSITION SUMMARY: The CAPA Specialist is responsible 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.