Quality Engineer

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

For Quality/ Validation services in the Engineering area.

WHAT MAKES YOU A FIT:

THE TECHNICAL PART:

• Bachelor's Degree in Mechanical, Electrical, Industrial, Manufacturing, or Biomedical Engineering, or a relatedfield, and 10+ years of experience within the regulated industry.
• Bilingual (English & Spanish).
• Shift: Administrative shift and according to business needs.
• Experience in:
  • Validations
  • Data analysis
  • Statistical analysis
  • Sampling sizes determination

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Key Responsibilities include, but are not limited to, the following:

• 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.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!

Are you the next piece?