Quality Engineer - Medical Device

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

Experience Required: 10+ Years
Education: Bachelor's Degree in Engineering
Industry: Medical Devices
Location:Puerto Rico

Position 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.

The ideal candidate will have extensive experience evaluating manufacturing and quality data, identifying trends, assessing process performance, and applying statistical methods to support quality improvements and data-driven decision-making.

Key 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 process performance data.

Apply statistical methods to determine and justify appropriate sampling sizes based on quality requirements, process capability, and risk assessments.

Conduct statistical evaluations to assess process stability, consistency, and manufacturing performance.

Analyze inspection results, quality metrics, and process data to support technical assessments and continuous improvement initiatives.

Interpret statistical results and provide data-driven recommendations to support quality engineering decisions.

Prepare technical reports, statistical summaries, and documentation to communicate analysis results and recommendations.

Support validation activities through data analysis, statistical evaluations, and sampling strategies.

Collaborate with Quality, Manufacturing, and Engineering teams to evaluate process performance and support quality improvement initiatives.

Ensure compliance with applicable quality standards, regulatory requirements, and internal procedures.

Bachelor's Degree in Engineering.

10+ years of experience in Quality Engineering, Manufacturing Engineering, Validation, or related engineering roles.

Strong experience in data analysis and statistical analysis within a medical device manufacturing environment.

Proven experience in sampling plans, sampling size determination, and statistical methodologies.

Experience analyzing manufacturing process data, in-process inspection results, and quality performance indicators.

Strong understanding of medical device manufacturing processes and quality requirements.

Experience supporting validation activities and statistical evaluations.

Ability to interpret complex datasets and provide technical recommendations.

Strong analytical, problem-solving, and technical documentation skills.

Preferred Qualifications

Proficiency in statistical analysis tools such as Minitab, JMP, or equivalent software.

Knowledge of Statistical Process Control (SPC), process capability analysis (Cp/Cpk), and statistical sampling techniques.

Familiarity with FDA regulations and ISO 13485 requirements.

Experience with risk-based sampling methodologies and quality improvement initiatives.

Knowledge of process validation, IQ/OQ/PQ, and statistical techniques used in regulated manufacturing environments.

Ultimate Solutions Corp. is an Equal Opportunity Employer.