Quality Engineer II: Med Device QA & Validation

FITS LLC; Humacao (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

FITS LLC provides engineering services for the Manufacturing sector and is seeking an engineer in Puerto Rico. The candidate should hold a Bachelor’s degree in Mechanical, Biomedical, Industrial, or Chemical Engineering and have 3+ years in the Medical Devices industry.

Bilingual in Spanish and English and strong teamwork are required. You will work with engineering and manufacturing to ensure quality standards, perform inspections and validation activities, and use data tools like Minitab, JMP,

Qualifications

• Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial or Chemical).
• 3+ years in the Medical Devices industry or equivalent exposure.
• Bilingual in Spanish and English.
• Strong teamwork and communication skills.
• Experience in FDA/ISO-regulated manufacturing environments and validation (IQ/OQ/PQ).
• Familiarity with GMP, CAPA, and risk management is preferred.

Responsibilities

• Develops and maintains quality standards and protocols for materials and finished products.
• Collaborates with engineering and manufacturing to implement quality controls.
• Implements inspection, testing, and evaluation methods for product and equipment.
• Designs inspection/testing mechanisms and documents results.
• Performs quality assurance tests and statistical analyses.
• Uses tools like Minitab, JMP, Excel, and Power BI for data analysis and reporting.
• Supports Lean Six Sigma initiatives and continuous improvement.

Skills

Mechanical Eng

Biomedical Eng

Industrial Eng

Chemical Eng

Bilingual (Spanish/English)

Teamwork

GMP ISO

Problem solving

Education

Bachelor’s in Mechanical Engineering

Bachelor’s in Biomedical Engineering

Bachelor’s in Industrial Engineering

Tools

Minitab

JMP

Excel

Power BI

SAP

Job description

FITS LLC provides engineering services for the Manufacturing sector and is seeking an engineer in Puerto Rico. The candidate should hold a Bachelor’s degree in Mechanical, Biomedical, Industrial, or Chemical Engineering and have 3+ years in the Medical Devices industry.

Bilingual in Spanish and English and strong teamwork are required. You will work with engineering and manufacturing to ensure quality standards, perform inspections and validation activities, and use data tools like Minitab, JMP,