Bilingual Quality Engineer, MedTech & Process Excellence

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

Job summary

Johnson & Johnson is seeking a Quality Engineer in San Lorenzo, PR to maintain high-quality standards across manufacturing processes. You will lead, support and optimize quality systems, participate in audits, and drive problem solving with tools like FMEA and RCA.

The role requires strong understanding of Design Control and Process Validation, with flexibility for varied shifts and potential travel. The ideal candidate has at least 2 years in a regulated environment, preferably with Medical

Qualifications

• Bachelor's degree in Engineering or Applied Science.
• Minimum 2 years of experience in a regulated industry; medical device experience preferred.
• Fully bilingual Spanish and English.
• EIT or PE license is preferred.
• Knowledge of QSR and ISO standards.

Responsibilities

• Ensure compliance with quality systems (Design Control, Process Validation, etc.).
• Lead and support investigations of non-conformances (NCR, CAPA, Audit Observations).
• Apply quality tools (FMEA, RCA, DOE) for process/product improvements.
• Assist with internal and external audits and supplier assessments.
• Develop, write and approve quality policies and procedures.

Skills

Bilingual Spanish & English

Regulatory knowledge

Education

Bachelor's degree in Engineering or Applied Science

Job description

Johnson & Johnson is seeking a Quality Engineer in San Lorenzo, PR to maintain high-quality standards across manufacturing processes. You will lead, support and optimize quality systems, participate in audits, and drive problem solving with tools like FMEA and RCA.

The role requires strong understanding of Design Control and Process Validation, with flexibility for varied shifts and potential travel. The ideal candidate has at least 2 years in a regulated environment, preferably with Medical