Quality Engineer I, Medical Devices

FITS LLC; Humacao (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

FITS LLC in Humacao, PR is seeking a quality-focused Engineer to support manufacturing and medical devices quality activities. You will work across engineering and production to maintain standards, perform tests, and drive continuous improvements.

The role requires a Bachelor’s degree in engineering and 3 years in the Medical Devices Industry, with bilingual Spanish/English communication and strong teamwork skills. Shift coverage includes 1st and 2nd shifts as needed.

Qualifications

• Bachelor’s Degree in Mechanical, Biomedical, Industrial or Chemical Engineering and three years exposure in Medical Devices Industry.
• Bilingual Spanish and English.
• Soft Skills: Excellent teamwork skills.
• Shift: 1st & 2nd Shift as needed.
• Experience in manufacturing process and quality activities; investigations, validation deliverables, risk assessments, and product/process performance monitoring.

Responsibilities

• Develops, modifies, applies, and maintains quality standards and protocol for processing materials into finished products.
• Collaborates with engineering and manufacturing to ensure quality standards are in place.
• Devises and implements methods for inspecting, testing, and evaluating products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment.
• Conducts quality assurance tests.
• Performs statistical analysis to assess costs and responsibility for non-conforming products.
• Ensures corrective actions meet reliability standards and are documented per requirements.
• Specializes in areas like design, incoming material, production control, product evaluation and reliability as needed.

Skills

Bilingual English/Spanish

Teamwork

Quality assurance

Statistical analysis

Problem solving

Education

Bachelor’s degree in Mechanical / Biomedical / Industrial / Chemical Engineering

Tools

Validation deliverables

Risk assessments

Process monitoring

Job description

FITS LLC in Humacao, PR is seeking a quality-focused Engineer to support manufacturing and medical devices quality activities. You will work across engineering and production to maintain standards, perform tests, and drive continuous improvements.

The role requires a Bachelor’s degree in engineering and 3 years in the Medical Devices Industry, with bilingual Spanish/English communication and strong teamwork skills. Shift coverage includes 1st and 2nd shifts as needed.