Quality Engineer I: Medical Device Manufacturing

fitspr; Humacao (PR); On-site; USD 65,000 - 85,000; Full time

Job summary

FITS is seeking an engineering professional to join our manufacturing quality team in Puerto Rico. The role focuses on advancing quality standards, collaborating with engineering and production, and implementing inspection and testing methods for materials and finished goods.

The ideal candidate holds a Bachelor’s degree in engineering, is bilingual (Spanish/English), and has hands-on experience with quality activities, investigations, validations, risk assessments, and monitoring product

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Industrial or Chemical Engineering.
• Bilingual Spanish and English.
• Soft skills: Excellent teamwork skills.
• Shift: 1st & 2nd Shift per business needs.
• Experience in manufacturing process and quality activities, investigations, validation deliverables, risk assessments, and product/process performance monitoring.

Responsibilities

• Develops, applies, and maintains quality standards and protocols for processing materials into finished products.
• Collaborates with engineering and manufacturing to ensure quality standards are in place.
• Implements inspection and testing methods and equipment to ensure precision and reliability.
• Conducts quality assurance tests and statistical analyses to identify non-conforming products or materials.
• Ensures documentation and corrective actions meet requirements.

Skills

Bilingual Spanish-English

Teamwork

Quality assurance

Education

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

Job description

FITS is seeking an engineering professional to join our manufacturing quality team in Puerto Rico. The role focuses on advancing quality standards, collaborating with engineering and production, and implementing inspection and testing methods for materials and finished goods.

The ideal candidate holds a Bachelor’s degree in engineering, is bilingual (Spanish/English), and has hands-on experience with quality activities, investigations, validations, risk assessments, and monitoring product