Quality Engineer II - Medical Device Quality & Compliance

MED Medtronic Inc; Tempe (AZ); On-site; USD 71,000 - 119,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Tuition assistance

Employee Stock Purchase Plan

Job summary

Medtronic Tempe Campus is seeking a Quality Engineer II to oversee quality and compliance for the process development and manufacturing of implantable cardiac and neuromodulation devices.

The role partners with engineering and operations to drive key quality initiatives across Tempe's Wafer & Sensor Operations and Hybrid Manufacturing Operations, with patient safety and regulatory compliance at the forefront.

Qualifications

• Requires a degree in Engineering, Science or technical field with 2+ years of relevant experience OR a Master's degree with 0+ years relevant experience.
• Experience with electronics manufacturing including wafer fabs and microelectronics assembly preferred.
• Six Sigma or Lean Sigma belt certification preferred.
• Experience with supporting internal or external audits including FDA, MDSAP and/or TUV preferred.

Responsibilities

• Develops and maintains quality standards and protocols for materials processing.
• Ensures internal quality processes comply with governing standards.
• Collaborates with engineering and manufacturing to uphold quality standards.
• Implements inspection/testing methods and analyzes product and equipment quality.
• Supports CAPA investigations and improvements and effectiveness verification.
• Leads or supports investigations of non-conforming product and communicates findings.

Skills

Quality engineering

Statistical analysis

DOE

CAPA

Education

Engineering degree

Master's degree

Job description

Medtronic Tempe Campus is seeking a Quality Engineer II to oversee quality and compliance for the process development and manufacturing of implantable cardiac and neuromodulation devices.

The role partners with engineering and operations to drive key quality initiatives across Tempe's Wafer & Sensor Operations and Hybrid Manufacturing Operations, with patient safety and regulatory compliance at the forefront.