Quality Engineer

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

Education: Bachelor's Degree in Engineering

Industry: Medical Devices

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.