Quality Engineer - Medical Device

Ultimate Solutions • Caguas, PR

1d

About The Position

Ultimate Solutions Corp. is seeking an experienced Quality Engineer to support medical device manufacturing. The role focuses on data analysis, statistical analysis, validation, and sampling methodologies. The Quality Engineer evaluates manufacturing and quality data, identifies trends, assesses process performance, and applies statistical methods to support quality improvements and data-driven decisions.

The position collaborates with Quality, Manufacturing, and Engineering teams to evaluate process performance and advance quality improvement initiatives. It also supports validation through data analysis, statistical evaluations, and sampling strategies, while ensuring compliance with applicable quality standards, regulatory requirements, and internal procedures.

Requirements

• 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 with 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.

Nice To Haves

• 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.

Responsibilities

• Perform 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 methodologies using statistical techniques and process performance data.
• Use statistical methods to determine and justify sampling sizes based on quality requirements, process capability, and risk assessments.
• Conduct statistical evaluations of process stability, consistency, and manufacturing performance.
• Analyze inspection results, quality metrics, and process data to support technical assessments and continuous improvement.
• Interpret statistical results and provide data-driven recommendations for quality engineering decisions.
• Prepare technical reports, statistical summaries, and documentation communicating 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior