Senior Quality Engineer - Medical Devices & Compliance

Medtronic; Tempe (AZ); On-site; USD 98,000 - 148,000; Full time

Job summary

Medtronic in Tempe, AZ seeks a Senior Quality Engineer to lead quality and compliance for implantable Cardiac and Neuromodulation devices. You will partner with engineering and operations to support quality initiatives across Wafer & Sensor Operations and Hybrid Manufacturing.

Emphasis on design outputs, process validation, and risk management enables high product quality. The role requires a degree in Engineering, Science or a technical field with multi-year experience in medical device

Qualifications

• Requires a degree in Engineering, Science or technical field with 4+ years of relevant experience, or higher degrees with proportionate experience.

Responsibilities

• Develops and maintains quality standards and protocols for processing materials into finished products.
• Ensures internal quality processes and systems comply with governing standards (ISO, FDA-GMP, etc.).
• Collaborates with engineering and manufacturing to meet quality standards.
• Implements methods for inspecting, testing and evaluating products and equipment.
• Supports risk assessments and design outputs with cross-functional teams.
• Drives CAPA investigations, improvements and verification testing.
• Leads change-control procedures and communicates actions to stakeholders.

Skills

Electronics manufacturing

Quality engineering

DOE & statistics

Process validation

CAPA investigations

Regulatory compliance

Six Sigma / Lean Sigma

DFSS / DRM

Quality metrics & reporting

Technical communication

Education

Baccalaureate degree in Engineering, Science or technical field

Master's degree in Engineering, Science or technical field

PhD in Engineering, Science or technical field

Job description

Medtronic in Tempe, AZ seeks a Senior Quality Engineer to lead quality and compliance for implantable Cardiac and Neuromodulation devices. You will partner with engineering and operations to support quality initiatives across Wafer & Sensor Operations and Hybrid Manufacturing.

Emphasis on design outputs, process validation, and risk management enables high product quality. The role requires a degree in Engineering, Science or a technical field with multi-year experience in medical device