Data-Driven Quality Engineer - Medical Device Validation

Ultimate Solutions; San Lorenzo (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

Ultimate Solutions Corp. seeks an experienced Quality Engineer with strong data and statistical analysis skills in the medical device manufacturing sector.

The role focuses on evaluating manufacturing data, trends, and process performance to drive quality improvements and data-driven decisions. The engineer will lead sampling plans, validation support, and cross-functional collaboration with Quality, Manufacturing, and Engineering teams to ensure compliance with FDA/ISO requirements and internal

Qualifications

• Bachelor's or higher degree in engineering or related field.
• 10+ years of experience in Quality/Manufacturing Engineering or related roles in medical device manufacturing.
• Strong data analysis and statistical analysis experience in medical devices.
• Experience with sampling plans, sizing, and statistical methodologies.

Responsibilities

• Perform comprehensive data analysis and statistical evaluations to assess manufacturing process performance and product quality.
• Analyze manufacturing and in-process quality data to identify trends, variations, and opportunities for improvement.
• Evaluate sampling plans and sampling methodologies using statistical techniques and data.
• Apply statistical methods to determine sampling sizes based on quality requirements, process capability, and risk.
• Conduct statistical evaluations to assess process stability and manufacturing performance.
• Interpret results and provide data-driven recommendations for quality decisions.
• Prepare technical reports and documentation communicating analysis results and recommendations.
• Support validation activities through data analysis and sampling strategies.
• Collaborate with Quality, Manufacturing, and Engineering to evaluate process performance and drive improvements.
• Ensure compliance with quality standards, regulatory requirements, and internal procedures.

Skills

Data analysis

Statistical analysis

Quality engineering

Validation

Sampling methodologies

Process performance

Data-driven decisions

Education

Bachelor's degree in Engineering

Tools

Minitab

JMP

Job description

Ultimate Solutions Corp. seeks an experienced Quality Engineer with strong data and statistical analysis skills in the medical device manufacturing sector.

The role focuses on evaluating manufacturing data, trends, and process performance to drive quality improvements and data-driven decisions. The engineer will lead sampling plans, validation support, and cross-functional collaboration with Quality, Manufacturing, and Engineering teams to ensure compliance with FDA/ISO requirements and internal