Quality Engineer II: Drive Quality & Process Improvement

Regulatory Jobs; Juncos (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

Medtronic in Puerto Rico is seeking a Quality Engineer to join the Quality function, partnering with manufacturing, operations, engineering, and quality systems to ensure products and processes meet regulatory requirements and quality standards.

This onsite role at the Juncos facility supports daily operations, data analysis, investigations, CAPA, and process validation activities while driving continuous improvement and compliant product quality.

Qualifications

• Bachelor's degree in Engineering with 2+ years in Quality Engineering or regulated environments.
• Experience supporting quality systems in manufacturing or regulated settings.
• Experience with investigations, root cause analysis, and CAPA.
• Experience with quality data analysis and statistical evaluation.
• Knowledge of process validation, equipment qualification, or product quality control.

Responsibilities

• Develop, implement, and maintain quality standards, procedures, and inspection protocols for materials, components, and finished products.
• Partner with engineering and manufacturing teams to integrate quality requirements into products and processes.
• Design and implement inspection, testing, and evaluation methods to verify quality.
• Perform quality assurance activities, including data analysis and statistical evaluations.
• Investigate nonconformances and root causes to support corrective and preventive actions.
• Ensure quality records and documentation comply with regulatory and quality system requirements.
• Provide oversight for equipment qualification and process validation.
• Collaborate with cross-functional teams to improve reliability and quality performance.

Skills

Quality Engineering

GMP

Regulatory compliance

Data analysis

CAPA

Education

Bachelor's degree in Engineering

Master's degree

Tools

eQMS

Statistical analysis

Job description

Medtronic in Puerto Rico is seeking a Quality Engineer to join the Quality function, partnering with manufacturing, operations, engineering, and quality systems to ensure products and processes meet regulatory requirements and quality standards.

This onsite role at the Juncos facility supports daily operations, data analysis, investigations, CAPA, and process validation activities while driving continuous improvement and compliant product quality.