Senior Quality Engineer, Medical Devices (Onsite)

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

Benefits offered by this job

Health, dental and vision insurance

401(k) with company match

Tuition assistance/reimbursement

Paid time off and holidays

Well-being programs

Job summary

Medtronic plc in Tempe is seeking a Senior Quality Engineer to oversee quality and compliance for process development and manufacturing of implantable medical devices. You will partner with engineering and operations to drive quality initiatives across Wafer & Sensor Operations and Hybrid Manufacturing Operations.

The role requires at least 4 years in engineering or quality, with strong knowledge of statistics, DOE, and regulatory standards (ISO, FDA).

Qualifications

• Requires a degree in Engineering, Science or technical field and a minimum of 4 years of relevant experience in Engineering and/or Quality.
• Master's degree with a minimum of 2 years relevant experience or PhD with 0 years relevant experience.
• Experience in medical device manufacturing and understanding of quality systems is essential.

Responsibilities

• Develops, maintains and improves quality standards and protocols for materials to finished products.
• Ensures compliance with internal quality processes and external regulatory standards (ISO, FDA, GMP).
• Collaborates with engineering and operations to ensure product quality and process effectiveness.
• Designs inspection/testing mechanisms and conducts QA tests and statistical analyses.
• Supports CAPA investigations and change controls; leads cross-functional investigations as needed.
• Communicates technical issues clearly and drives corrective actions.

Skills

Quality engineering

Regulatory knowledge

Process validation

Statistical analysis

DOE (design of experiments)

CAPA investigations

Risk assessment

Education

Bachelor's degree in Engineering/Science/Technical field

Master's degree in Engineering/Science

PhD in Engineering/Science

Tools

IQ (Installation Qualification)

OQPQ (Operation/Qualification)

FDA audits experience

MDSAP/ISO regulatory knowledge

Job description

Medtronic plc in Tempe is seeking a Senior Quality Engineer to oversee quality and compliance for process development and manufacturing of implantable medical devices. You will partner with engineering and operations to drive quality initiatives across Wafer & Sensor Operations and Hybrid Manufacturing Operations.

The role requires at least 4 years in engineering or quality, with strong knowledge of statistics, DOE, and regulatory standards (ISO, FDA).