Senior Quality Engineer - Data Analytics for Med Devices

Ultimate Solutions Corp; Caguas (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Ultimate Solutions Corp. is seeking an experienced Quality Engineer with a strong background in data analysis, statistical analysis, validation, and sampling methodologies within the medical device manufacturing industry in Puerto Rico.

The ideal candidate will evaluate manufacturing and quality data, identify trends, assess process performance, and apply statistical methods to support quality improvements and data-driven decision-making.

Qualifications

• Bachelor's Degree in Engineering required.
• 10+ years of experience in Quality Engineering, Manufacturing Engineering, Validation, or related roles.
• Strong experience with data analysis and statistical analysis in a medical device manufacturing environment.
• Proven experience in sampling plans, sampling size determination, and statistical methodologies.

Responsibilities

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

Skills

Data analysis

Statistical analysis

Sampling methodologies

Regulatory compliance

Education

Bachelor's Degree in Engineering

Tools

Minitab

JMP

Job description

Ultimate Solutions Corp. is seeking an experienced Quality Engineer with a strong background in data analysis, statistical analysis, validation, and sampling methodologies within the medical device manufacturing industry in Puerto Rico.

The ideal candidate will evaluate manufacturing and quality data, identify trends, assess process performance, and apply statistical methods to support quality improvements and data-driven decision-making.