Quality Engineer I — Bilingual (Spanish/English) in Medical Devices

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

Job summary

FITS, LLC in Puerto Rico is seeking a Quality Engineer to contribute to the manufacturing quality system for our medical devices clients. The role focuses on developing, applying, and maintaining quality standards and protocols for processing materials into finished products, and working closely with engineering and manufacturing teams to ensure compliance.

The candidate will conduct QA tests, perform statistical analyses, and implement corrective actions to meet reliability requirements, while

Qualifications

• Bachelor's degree in engineering and three years of exposure within the Medical Devices Industry.
• Bilingual in Spanish and English.
• Strong teamwork and communication skills.

Responsibilities

• Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials products.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment.
• Conducts quality assurance tests.
• Performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control, and/or research.

Skills

Bilingual: Spanish and English

Excellent teamwork skills

Education

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

Job description

FITS, LLC in Puerto Rico is seeking a Quality Engineer to contribute to the manufacturing quality system for our medical devices clients. The role focuses on developing, applying, and maintaining quality standards and protocols for processing materials into finished products, and working closely with engineering and manufacturing teams to ensure compliance.

The candidate will conduct QA tests, perform statistical analyses, and implement corrective actions to meet reliability requirements, while