Senior Quality Engineer: Process Excellence & CAPA Leader

Johnson & Johnson MedTech

Dallas (TX)

On-site

USD 90,000 - 130,000

Full time

2 days ago

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Job summary

Johnson & Johnson is seeking a Staff Quality Engineer in Irving, TX to provide strategic direction across Quality Systems, Nonconformance, CAPA, and Process Validation. This senior role mentors quality professionals and leads cross-functional initiatives with Operations, Engineering, Supply Chain, Manufacturing, and Regulatory teams.

You will drive high-impact investigations, strengthen process capability, support site quality strategies, and ensure regulatory compliance to improve product

Qualifications

Bachelor’s degree in engineering or related technical field required.
Minimum 6 years of related manufacturing experience preferred.
Knowledge of ISO13485 and/or cGMP regulations.
ASQ certification or Six Sigma/Process Excellence certification preferred.
Strong project leadership and cross-functional collaboration skills.

Responsibilities

Lead complex quality investigations for product/process/nonconformance.
Drive CAPA programs and systemic quality improvements.
Oversee process validations, revalidations, and equipment qualifications.
Provide risk assessments (DFMEA/PFMEA) and support QA strategies.
Mentor quality professionals and influence stakeholders across functions.
Ensure regulatory compliance and quality system effectiveness.

Skills

Quality Engineering

CAPA

Process Validation

Regulatory Compliance

Risk Management

Education

Bachelor's degree in engineering

Tools

Statistics

SPC

DOE

Job description

You will drive high-impact investigations, strengthen process capability, support site quality strategies, and ensure regulatory compliance to improve product

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