Quality Systems Project Engineer

• Support the Ethicon Quality System by driving CAPA/NC data analysis, robust failure investigations, and quality improvement initiatives
• Track and report CAPA/NC action plans and support root cause analysis and Quality System improvement
• Provide training on Quality Management System elements, including CAPA, NC, DRB, Management Review, Quality Planning, Quality Manuals, and Metrics
• Partner with Med Tech Quality Business Enablement and E2E Productivity & Innovation Q&C on Quality projects
• Manage cross-site citizen-developed applications according to the Master Validation Plan
• Facilitate and support Quality System meetings
• Monitor and report Quality Management System metrics
• Coordinate technical teams and lead cross-functional teams on complex investigations, experimental design, data analysis, CAPA implementation, verification, validation, and closure
• Identify continuous improvement opportunities aligned with quality and business objectives
• Support, participate in, and lead cross-functional projects
• Provide audit support for Registrar, Notified Body, FDA, and customer audits
• Complete assessments for internal and external standards and regulations across Ethicon sites
• Process document changes and maintain Franchise Quality Manuals and Quality Planning procedures
• Lead optimization and harmonization Quality projects across Ethicon
• Ensure personal and Company compliance with applicable regulations, policies, and procedures
• Perform other assigned duties

• Bachelor of Science or equivalent degree in Engineering, Sciences, or Business Analysis required
• Minimum of 4–6 years of experience in Operations, Manufacturing, Quality, and/or Engineering
• Experience working in an FDA-regulated environment
• Strong communication, human relation, problem-solving, and analytical skills
• Demonstrated root cause analysis and failure investigation skills
• Ability to communicate effectively with all levels of management and functions
• Experience with FDA, notified body, or other Health Authority audits/inspections
• Ability to travel domestically up to 10%
• Preferred: demonstrated project management skills
• Preferred: ability to build collaboration, partnership, and teamwork across local and global organizations
• Preferred: demonstrated problem-solving and analytical skills
• Preferred: leadership skills without direct authority
• Preferred: effectiveness as a team member and team leader

Demonstrates expertise in Quality Management Systems, including CAPA, NC, and root cause analysis, while effectively leading cross-functional teams and managing quality improvement initiatives in FDA-regulated environments.

• CAPA Implementation
• Root Cause Analysis
• Quality Management System
• FDA Regulatory Experience
• Project Management

• Data Analysis
• Failure Investigation
• Quality Improvement
• Quality Planning
• Metrics Monitoring
• Document Change Processing
• Audit Support
• Experimental Design
• Validation
• Verification

• Strong Communication
• Problem-Solving
• Human Relation
• Team Leadership
• Collaboration

• FDA
• Notified Body
• Health Authority Audits
• Quality System
• Continuous Improvement
• Cross-Functional Projects
• Master Validation Plan
• Franchise Quality Manuals
• Quality Metrics
• Quality Projects