Quality Engineer – Medical Devices & Process Excellence

Johnson & Johnson; San Lorenzo (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Johnson & Johnson is hiring a Quality Engineer for the San Lorenzo, PR facility. The role focuses on maintaining high-quality standards in product manufacturing and regulatory compliance.

You will lead quality initiatives, perform audits, analyze non-conformances, and apply quality tools to drive process improvements. The position requires bilingual Spanish/English skills and a degree in engineering or applied science.

Qualifications

• Bachelor's degree or equivalent in Engineering or Applied Science.
• At least 2 years in a regulated industry, medical device preferred.
• Fully bilingual in Spanish & English.
• EIT or PE license is a plus.

Responsibilities

• Supports internal compliance, audits, and training per QSR/ISO.
• Ensures safety, good housekeeping, and manufacturing practices.
• Leads investigations of non-conformances and CAPA actions.
• Applies QSR/ISO quality tools (FMEA, RCA, DOE) to improve products and processes.
• Develops and approves quality policies, test methods, and specifications.
• Supports plant sterilization and design transfer activities.

Skills

Bilingual English/Spanish

2+ years regulated industry

Computer skills

Education

Bachelor's or equivalent University degree

Job description

Johnson & Johnson is hiring a Quality Engineer for the San Lorenzo, PR facility. The role focuses on maintaining high-quality standards in product manufacturing and regulatory compliance.

You will lead quality initiatives, perform audits, analyze non-conformances, and apply quality tools to drive process improvements. The position requires bilingual Spanish/English skills and a degree in engineering or applied science.