Quality Systems Project Engineer

Johnson & Johnson

Quality Systems Project Engineer improving CAPA, investigations, and compliance for Johnson & Johnson’s medical-device business. Leading cross-functional quality projects, audits, metrics, and process harmonization across Ethicon sites.

Posted 8/5/2026full-timeRaritan • New Jersey, Ohio • 🇺🇸 United StatesMid-LevelSenior💰 $94,000 - $151,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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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.

Highest-signal resume keywords

CAPA ImplementationRoot Cause AnalysisQuality Management SystemFDA Regulatory ExperienceProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data AnalysisFailure InvestigationQuality ImprovementQuality PlanningMetrics MonitoringDocument Change ProcessingAudit SupportExperimental DesignValidationVerification

Soft Skills

Strong CommunicationProblem-SolvingHuman RelationTeam LeadershipCollaboration

Industry Keywords

FDANotified BodyHealth Authority AuditsQuality SystemContinuous ImprovementCross-Functional ProjectsMaster Validation PlanFranchise Quality ManualsQuality MetricsQuality Projects

About the role

Key responsibilities & impact

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 MedTech 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

Requirements

What you’ll need

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

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time – up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Inclusive interview process and disability accommodations