Quality Engineer II- BH

Careers that change lives start here. 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. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Quality Engineering function within Service and Repair is responsible for ensuring compliance, product quality, supplier quality technical support and continuous improvement across service center and field service operations. This team partners closely with Engineering, Regulatory, Supplier Quality, Post-Market Quality, and Operating Units to support quality system requirements, continuous improvement initiatives, supplier management, audit readiness, and the introduction and sustainment of products throughout the service lifecycle. The Service & Repair Quality Engineer II provides quality engineering support for a global Service and Repair organization. This role partners cross-functionally to maintain compliance with quality system requirements, support daily operations, drive resolution of quality issues, support supplied products and processes, and ensure audit readiness across service center and field service activities. The Quality Engineer II also plays a key role in Corrective and Preventive Action (CAPA) activities, process validation efforts, and continuous improvement initiatives that support operational performance and product quality.     This role is based in Milton, Ontario and requires onsite presence 5 days per week to support manufacturing and service operations. Travel is expected to be 15% or less.   Primary 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 (including review and approval) to ensure performance, compliance and regulatory requirements are met and properly documented. • Review/prepare test plans and reports (qualification, validation) for change and improvement activities (supplier certifications, material/sub-supplier changes and supplier performed special processes); leveraging the Production Part Approval Process (PPAP) when required. • Conduct audit/assessment of current or future suppliers ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements. • Monitor, analyze, and communicate quality metrics, performance trends, and improvement opportunities to stakeholders. • Lead quality walks, facilitate resolution of identified gaps, and track actions through completion. • Initiate, manage, and support Supplier Action Requests (SAR) and Supplier Corrective and Preventive Actions (SCAPA) in accordance with applicable procedures and escalation criteria. • Support internal and external audits by coordinating audit readiness activities and representing the service organization during audit interactions. • Contribute to continuous improvement initiatives across areas including incoming inspection, inventory control, production processes, product ev