Senior Quality Engineer - Validation & Data Analytics

FITS LLC; San Lorenzo (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

FITS LLC in Puerto Rico is seeking a skilled Quality/Validation engineer to support validation activities, data analysis, and process improvement in the manufacturing environment. The role emphasizes statistical methods, sampling, and documentation to ensure compliance with quality criteria.

The candidate should hold a Bachelor's degree in Engineering and possess 10+ years of experience in regulated industries, with bilingual English/Spanish abilities.

Qualifications

• Bachelor's degree in engineering and 10+ years in regulated industry.
• Bilingual in English and Spanish.
• Shift: Administrative shift and according to business needs.

Responsibilities

• Perform in-process data analysis to evaluate manufacturing and quality performance.
• Conduct statistical analysis to identify process trends, variability, and potential quality concerns.
• Determine appropriate sample sizes and sampling strategies based on statistical principles and process requirements.
• Support the execution and documentation of validation activities, including analysis of validation data.
• Evaluate validation and manufacturing data to confirm compliance with established acceptance criteria and quality requirements.
• Apply statistical techniques to assess process capability and process performance.
• Review and interpret quality and process data to support data-driven decision-making and continuous improvement initiatives.
• Provide technical Quality Engineering support related to validations, statistical evaluations, sampling methodologies, and process data analysis.

Skills

Bilingual (English & Spanish)

Data analysis

Statistical analysis

Sampling methods

Validations

Quality engineering support

Education

Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, or Biomedical Engineering

Job description

FITS LLC in Puerto Rico is seeking a skilled Quality/Validation engineer to support validation activities, data analysis, and process improvement in the manufacturing environment. The role emphasizes statistical methods, sampling, and documentation to ensure compliance with quality criteria.

The candidate should hold a Bachelor's degree in Engineering and possess 10+ years of experience in regulated industries, with bilingual English/Spanish abilities.