Quality Engineering (MedTech)

Location: San Lorenzo, Puerto Rico, United States of America; onsite. Availability for 1st, 2nd, and 3rd shifts or 12-hour shifts, including weekends and holidays, may be required. Up to 10% domestic travel may be required.

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions across the spectrum of patient care.

What you will do

• Maintain and improve quality systems supporting medical device manufacturing and regulatory compliance.
• Provide technical support to Plant Operations and Quality Assurance during product and process design, development, validation, and implementation.
• Investigate nonconformances, CAPAs, audit observations, and material disposition while determining product impact and scope.
• Apply FMEA, root cause analysis, statistical analysis, and DOE to resolve product and process issues.
• Develop, write, and approve policies, procedures, test methods, and specifications.
• Support internal, supplier, contractor, and laboratory audits, sterilization processes, design transfer, and day-to-day manufacturing troubleshooting.

Requirements

• Bachelor’s degree or equivalent university degree, preferably in Engineering or Applied Science.
• At least 2 years of work experience, including at least 1 year in a regulated industry; medical device experience is preferred.
• Fully bilingual Spanish and English communication skills required.
• Knowledge of QSR and ISO standards.
• Intermediate or higher computer and software application skills.
• EIT or PE license is preferred.

Culture & Benefits

• Inclusive work environment focused on employee dignity, diversity, and equal opportunity.
• Work supporting healthcare innovation and medical technology manufacturing.
• Compliance with company, environmental, safety, occupational health, ISO 14001, and OSHA-related requirements.
• Opportunity to support plant initiatives, quality improvement projects, and cross-functional operations teams.