CAPA Engineer

CAPA Engineer

Requirements

• Bachelor’s Degree required
• 2 – 5 years’ related experience; or an advanced degree without experience; or equivalent directly related work experience
• Working knowledge of ISO 13485, 21 CFR Part 820.100
• Must understand and know how to navigate a CAPA through the Quality System
• Solid analytical and problem solving skills
• Demonstrates continuous improvement and consistent metrics to achieve business result and quality output
• Strong project management and organizational skills
• Excellent attention to detail, resourceful, self-reliant, self-motivated and confident
• Excellent verbal and written communication skills

Responsibilities

• Utilizes Quality System to ensure CAPA system is successful and compliant
• Partners with Quality Systems personnel and responsible to drive continuous improvement on Root Cause investigations and CAPA as a core Quality Business process/function(s)
• Responsible for assigned CAPAs and will provide guidance to CAPA team(s)
• Supports the rollout of any new CAPA solutions (tools, techniques, and/or process enhancements)
• Provides project direction, coaching, and mentoring for CAPA teams as required
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving CAPA and NC issues
• Use technical/compliance information to guide and influence CAPA, NC and Compliance strategies
• Ensure compliance to requirements and the consistency and quality of CAPA and NC execution
• Drive timely execution of CAPA and NC deliverables through monitoring and reporting status to CAPA and NC owners, CAPA Review Board and management
• Interface with management and peers to assess and improve the adequacy of the processes
• Provide support/responses during audits/inspections relating to the CAPA and NC system as required
• Develop and deliver CAPA and NC process training as required
• Ensure effective CAPA and NC data analysis and investigation, and evaluate their trending
• Builds productive working relationships
• May provide assistance to junior level staff with general tasks that require a better understanding of functions, as directed by immediate supervisor
• May refer to senior level staff for assistance with higher level problems that may arise
• Escalates issues to supervisor/manager for resolution, as deemed necessary
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations
• Assist with various projects as assigned by direct supervisor
• Other duties as assigned

Preferred Qualifications

No preferred qualifications provided.