Quality Engineer, Medical Devices & Process Excellence

7597-Ethicon LLC Legal Entity; United States; On-site; USD 65,000 - 85,000; Full time

Job summary

Johnson & Johnson is seeking a Quality Engineer to maintain high-quality standards for manufacturing processes and ensure regulatory compliance. The role reports to the Quality Operations Lead and requires knowledge of QSR/ISO standards and experience in a regulated environment.

Responsibilities include supporting audits, developing quality indicators, and applying advanced quality tools such as FMEA and DOE to drive process improvements.

Qualifications

• Bachelor’s degree in Engineering or Applied Science is required.
• Minimum 2 years of work experience with at least 1 year in a regulated industry.
• Fully bilingual Spanish and English is preferred.
• Knowledge of QSR and ISO Standards.

Responsibilities

• Supports Internal Compliance Function as required (QSR/ISO training, audits, trends analysis).
• Ensures compliance with safety, good housekeeping and manufacturing practices.
• Supports Operations in generating quality indicators and action plans to eliminate root causes of non-conformances.
• Lead and/or support Plant Initiatives and/or special projects.
• Applies Quality Engineering tools such as FMEA, RCA, DOE to improve products or processes.

Skills

Bilingual: Spanish & English

Quality engineering

QSR & ISO Standards

Regulated industry experience

Computer skills

Education

Bachelor's degree in Engineering or Applied Science

Job description

Johnson & Johnson is seeking a Quality Engineer to maintain high-quality standards for manufacturing processes and ensure regulatory compliance. The role reports to the Quality Operations Lead and requires knowledge of QSR/ISO standards and experience in a regulated environment.

Responsibilities include supporting audits, developing quality indicators, and applying advanced quality tools such as FMEA and DOE to drive process improvements.