Quality Engineer I: Medical Devices QA & Risk

Medtronic; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Medtronic is seeking a Quality Engineer I to support engineering activities related to product and process quality, materials changes, and equipment validation. The role collaborates with quality, manufacturing, regulatory, R&D and other partners to assess risk and ensure changes are executed in a controlled, compliant manner.

The ideal candidate holds a bachelor’s degree in engineering with 0 years of relevant experience and a passion for quality and continuous improvement within a global

Qualifications

• Bachelor degree in Engineering is required.
• Experience with regulatory agencies is a plus.
• Knowledge of Kepner-Tregoe or DMAIC methods is desirable.
• Familiarity with statistical techniques and risk management standards is preferred.

Responsibilities

• Develops, maintains and applies quality standards and protocols for materials and production processes.
• Collaborates with engineering and manufacturing to ensure quality systems are in place.
• Implements inspection and testing mechanisms; conducts QA tests and statistical analyses.
• Ensures corrective actions meet reliability standards and documentation compliance.
• May specialize in design, incoming materials, production control or reliability as applicable.
• Assists with validation requirements and change control activities.

Skills

Quality assurance

Regulatory knowledge

Statistical analysis

Risk management

Cross-functional collaboration

Education

Bachelor degree in Engineering

Job description

Medtronic is seeking a Quality Engineer I to support engineering activities related to product and process quality, materials changes, and equipment validation. The role collaborates with quality, manufacturing, regulatory, R&D and other partners to assess risk and ensure changes are executed in a controlled, compliant manner.

The ideal candidate holds a bachelor’s degree in engineering with 0 years of relevant experience and a passion for quality and continuous improvement within a global