Quality Engineer I — Data-Driven Quality & Compliance

Medtronic; Humacao (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Medtronic is a global leader in healthcare technology focused on alleviating pain, restoring health, and extending life. A Quality Engineer I supports product development, manufacturing, and lifecycle activities by ensuring quality systems and regulatory compliance.

The role emphasizes data-driven investigations, CAPA, and cross‑functional collaboration to prevent defects and improve processes in a fast-paced environment.

Qualifications

• Bachelor’s degree required; 0 years of relevant experience.
• Familiarity with MES, QMS, CAPA, and change management.
• Knowledge of FDA QSR and ISO 13485 standards.
• Experience with data analytics and statistics for investigations.
• Six Sigma/Lean exposure and DMAIC problem solving.
• Minitab or similar tools for trend analysis and root cause evaluation.
• Programming or scripting (Python, VBA) to automate data analysis.

Responsibilities

• Develops, applies and maintains quality standards and protocols for processing materials into finished products.
• Collaborates with engineering and manufacturing to ensure quality standards are in place.
• Designs and implements inspection and testing mechanisms; conducts statistical analyses.
• Ensures corrective actions meet reliability standards and documentation compliance.
• Supports audits, validations and risk management activities.
• Identifies quality risks and drives continuous improvement across functions.

Skills

Quality Assurance

Root Cause Analysis

Statistical Analysis

Cross-Functional Collaboration

Regulatory Knowledge

Data Analytics

Education

Bachelor's degree

Tools

Minitab

Python

VBA

QMS software

Job description

Medtronic is a global leader in healthcare technology focused on alleviating pain, restoring health, and extending life. A Quality Engineer I supports product development, manufacturing, and lifecycle activities by ensuring quality systems and regulatory compliance.

The role emphasizes data-driven investigations, CAPA, and cross‑functional collaboration to prevent defects and improve processes in a fast-paced environment.