Senior Quality Engineer - Process Excellence & CAPA Leader

Johnson & Johnson MedTech; Fort Worth (TX); On-site; USD 120,000 - 150,000; Full time

Job summary

Johnson & Johnson is seeking a Staff Quality Engineer to lead complex quality initiatives within Quality Operations at the Irving, TX site. You will direct nonconformances, CAPA, risk assessments, and validation activities across multiple functions to ensure compliance and product quality.

You’ll mentor quality professionals, influence stakeholders, and drive systematic improvements to meet regulatory standards and operational excellence.

Qualifications

• Bachelor's degree in engineering or related technical field required.
• Minimum 6 years related manufacturing experience desired.
• Knowledge of ISO13485 and/or cGMP regulations.
• ASQ CQE/CQA/Process Excellence certs preferred; Six Sigma certs appreciated.
• Strong project management and leadership skills; capable of leading cross-functional teams.

Responsibilities

• Provide technical leadership for complex product, process, supplier, and manufacturing nonconformance investigations.
• Lead site-level CAPA initiatives for systemic quality, compliance, and performance improvements.
• Lead quality investigations, trend analysis, and risk assessments across operations.
• Review and approve validation strategies, protocols, and reports; support process validations and changes.
• Drive defect reduction, data-driven improvements, and quality-system effectiveness.

Skills

Quality systems leadership

CAPA management

Process validation

Risk management

Statistical analysis

Lean Six Sigma

Nonconformance investigations

Project management

Education

Bachelor's degree in engineering or related technical field

Tools

SPC

DOE

PFMEA

Job description

Johnson & Johnson is seeking a Staff Quality Engineer to lead complex quality initiatives within Quality Operations at the Irving, TX site. You will direct nonconformances, CAPA, risk assessments, and validation activities across multiple functions to ensure compliance and product quality.

You’ll mentor quality professionals, influence stakeholders, and drive systematic improvements to meet regulatory standards and operational excellence.