Senior Quality Engineer - Medical Devices (Bilingual)

FITS LLC; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a qualified engineer for a QA/Quality role in the medical devices industry. The candidate will develop and maintain quality standards, validate equipment, and ensure compliance with FDA/ISO requirements, collaborating with engineering and manufacturing teams to drive continuous improvement.

The ideal person has an engineering degree, bilingual Spanish/English, and strong teamwork skills, with experience in equipment validation, quality systems, and change control.

Qualifications

• Bachelor’s degree in engineering field (Mechanical, Biomedical, Industrial or Chemical).
• Bilingual in Spanish and English.
• Strong teamwork and collaboration skills.

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.
• Implements inspection, testing, and evaluation methods for products and equipment.
• Designs or specifies inspection and testing mechanisms and equipment.
• Conducts quality assurance tests.
• Performs statistical analysis to assess product quality and responsibility for non-conforming items.
• Ensures corrective actions meet reliability standards and are well documented.
• May specialize in design, incoming material, production control, or reliability.

Skills

Bilingual: Spanish & English

Teamwork

Education

Bachelor’s Degree in Mechanical, Biomedical, Industrial or Chemical Engineering

Job description

FITS LLC in Puerto Rico seeks a qualified engineer for a QA/Quality role in the medical devices industry. The candidate will develop and maintain quality standards, validate equipment, and ensure compliance with FDA/ISO requirements, collaborating with engineering and manufacturing teams to drive continuous improvement.

The ideal person has an engineering degree, bilingual Spanish/English, and strong teamwork skills, with experience in equipment validation, quality systems, and change control.