Role Overview
The Service & Repair Quality Engineer II provides quality engineering support for a global Service and Repair organization, maintaining compliance with quality system requirements, driving resolution of quality issues, supporting supplied products and processes, and ensuring audit readiness across service center and field service activities.
About Medtronic
Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year.
Key Responsibilities
- Partner with Engineering, Supplier Quality, Design Quality, Regulatory, Post-Market Quality, and Operating Units to support quality system compliance and operational objectives.
- Develop, implement, and maintain quality standards, procedures, and controls within a service and repair environment.
- Provide quality oversight for validation and verification activities, nonconformance management, and Corrective and Preventive Action (CAPA) processes.
- Investigate quality issues, assess risk, and support implementation of effective corrective actions.
- Ensure that suppliers deliver quality parts, materials, and services.
- Coordinate and monitor change control process to ensure performance, compliance and regulatory requirements are met.
- Review and prepare test plans and reports for change and improvement activities.
- Conduct audit and assessment of current or future suppliers ensuring compliance with associated Medtronic policies and GMP/ISO requirements.
Requirements & Eligibility
- Bachelor’s Degree in Engineering, Science, or a technical field with 2+ years of engineering and/or quality experience OR an Advanced Degree in Engineering, Science, or a technical field with 0+ years of engineering and/or quality experience.
Required Skills & Tech
ISO 13485ISO 14971CAPAPPAPGMP