Quality Engineer

For Quality/ Validation services in the Engineering a rea.

About fitspr

• We are a Service Provider company different 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 industry clients with top-notch quality talent.
• We're FITS!
• Are you the next piece?

Responsibilities

• Administrative shift and according to business needs.
• Process Validations Data analysis
• Statistical analysis / Statistical assessments

Sampling sizes determination

• Sampling plans 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.

Requirements

• The Technical Part: Bachelor's Degree in Mechanical, Electrical, Industrial, Manufacturing, or Biomedical Engineering, or a related field, and 10+ years of experience within the regulated industry.
• Bilingual (English & Spanish).