Sr CAPA Engineer

Sr CAPA Engineer

Requirements

• Bachelor’s Degree required; Advanced Degree desirable
• 5 – 8 years’ related experience; or a Master’s degree with 3 years’ experience; or a PhD without experience; or equivalent directly related work experience
• Must understand and know how to navigate a CAPA through the Quality System
• Knowledge and experience in CAPA and medical device product documentation procedures with proven ability or project experience in developing systems and business processes to improve overall efficiency and productivity
• Working knowledge of ISO 13485, 21 CFR Part 820.100
• Ability to work cross-functionally with various groups that have opportunity to impact the CAPA outcome
• 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
• Strong project management and organizational skills
• Excellent verbal and written communication skills

Responsibilities

• Responsible for coaching CAPA Engineers to ensure CAPAs (corrective and preventive action) and Non-Conformance (NC) investigations are executed in compliance with company procedures and FDA Regulations
• Utilizes Quality System to ensure CAPA system is successful and compliant
• Partners with Quality Systems personnel and responsible for driving continuous improvement on effective CAPAs as a core Quality Business process/function(s)
• Responsible for assigned CAPAs and will act as CAPA lead to CAPA Owner/Team providing project direction throughout CAPA stages
• Performs Quality Approver functions for CAPA and NCs to ensure compliance to applicable procedures
• Applies sound, systematic problem-solving methodologies in identifying root cause, corrective action(s) and monitoring plan(s) for resolution of CAPA and NC issues
• Applies technical/compliance information to guide and influence CAPA/NC/Compliance strategies
• Ensures compliance to requirements and consistency/quality of CAPA and NC execution
• Drives timely execution of CAPA and NC deliverables through monitoring and reporting status to CAPA Review Board and management
• Supports the rollout of any new CAPA solutions (tools, techniques, and/or process enhancements)
• Interfaces with management and peers to assess and improve the adequacy of the processes
• Develops and delivers CAPA and NC process training as required
• Participates in weekly CAPA Review Board meetings
• May escalate issues to supervisor/manager for resolution, as deemed necessary
• Mentor other staff as applicable
• 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 a direct supervisor
• Other duties as assigned

Preferred Qualifications

• Experience participating in health authority and/or Notified Body inspections is preferred
• Availability to work different time zones as per business need