Quality Engineer II — GMP/ISO QA for Medical Devices

FITS, LLC; Humacao (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

FITS is seeking a Mechanical/Biomedical/Industrial/Chemical Engineer with 3 years in the Medical Devices Industry to join our manufacturing team in Puerto Rico. The candidate will uphold quality standards, support validation activities, and drive process improvements in a GMP/ISO environment.

The role requires bilingual Spanish/English and strong problem-solving, risk assessment, and data analysis skills. Collaboration with engineering, production, and QA is essential to ensure compliant,

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Industrial or Chemical Engineering.
• 3 years of exposure in the Medical Devices Industry.
• Bilingual: Spanish and English.
• Soft Skills: Excellent teamwork skills.
• Experience in FDA/ISO-regulated manufacturing environments.
• Knowledge of validation and manufacturing processes.
• Proficiency in problem-solving, risk assessment, and data analysis tools.
• Experience with quality and business systems (e.g., Minitab, JMP, Excel, Power BI, SAP).

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 inspection and testing mechanisms and equipment.
• Conducts quality assurance tests.
• Performs statistical analysis to assess costs and responsibility for nonconforming products or materials.
• Ensures corrective measures meet reliability standards and documentation is compliant.
• May specialize in design, incoming material, production control, product evaluation and reliability, inventory control, or research.
• Experience with GMP, ISO 13485, CAPA, nonconformance management, change control, document control, and risk management.
• Knowledge of validation and manufacturing processes (IQ/OQ/PQ), risk-based validation, and manufacturing controls.
• Proficiency in problem-solving, risk assessment, and data analysis tools (FMEA, 5 Whys, Fishbone, SPC, DOE, capability analysis, trending).
• Experience with quality and business systems (e.g., Minitab, JMP, Excel, Power BI, SAP) and strong communication, collaboration, continuous improvement, and critical-thinking skills; Lean Six Sigma and automation/programming experience are preferred.

Skills

Teamwork

Bilingual Spanish/English

Problem solving

Risk assessment

Data analysis

Education

Bachelor's degree in Mechanical or Biomedical or Industrial or Chemical Engineering

Tools

Minitab

JMP

Excel

Power BI

SAP

Job description

FITS is seeking a Mechanical/Biomedical/Industrial/Chemical Engineer with 3 years in the Medical Devices Industry to join our manufacturing team in Puerto Rico. The candidate will uphold quality standards, support validation activities, and drive process improvements in a GMP/ISO environment.

The role requires bilingual Spanish/English and strong problem-solving, risk assessment, and data analysis skills. Collaboration with engineering, production, and QA is essential to ensure compliant,