Quality Systems Specialist

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 Regional Compliance and Quality Systems (CQS) function supports quality management system (QMS) compliance, audit readiness, supplier quality oversight, and continuous improvement initiatives across the region. This team partners with operating units and quality stakeholders to ensure alignment with internal quality requirements, regulatory expectations, and industry standards, while driving consistency and effectiveness across audit and QMS processes.

The Quality Systems Specialist serves as a subject matter resource for internal and external audits, supplier audit activities, QMS projects, and compliance programs. The role works closely with cross-functional teams to monitor performance, support quality objectives, drive corrective actions, and strengthen compliance across regional operations.

The Quality Systems Specialist is responsible for supporting regional audit and quality management system activities, ensuring compliance with applicable quality requirements and industry regulations. This role provides guidance on audit programs, quality processes, performance metrics, and continuous improvement initiatives while partnering with stakeholders across the organization to strengthen quality system effectiveness.

Primary Responsibilities:

• Manage and support internal, external, and supplier audit activities, including audit observations and corrective action tracking.
• Provide training and guidance on audit processes, quality management system requirements, and TrackWise utilization.
• Monitor audit, change control, and QMS key performance indicators and develop corrective or mitigation plans when targets are not achieved.
• Partner with operating groups and quality stakeholders to monitor compliance activities and drive process improvements.
• Interpret quality policies, procedures, and regulatory requirements to ensure organizational compliance.
• Participate in audit and QMS-related projects and support implementation of process enhancements.
• Maintain assigned quality documents and processes in alignment with applicable QMS requirements.
• Support additional responsibilities and quality initiatives defined within regional service agreements.

Required Qualifications:

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Biomedical Engineering, or related scientific discipline with 3+ years of experience in a quality role within the healthcare industry.
• Experience with ISO 13485 and/or GxP requirements, including Good Distribution Practice (GDP) or Good Manufacturing Practice (GMP).
• Lead Auditor or Internal Auditor certification in a Quality Management System standard such as ISO 13485 or GMP.
• Fluent English communication skills.
• Experience managing projects and working across geographically dispersed teams. 

Preferred Qualifications:

• Experience writing, reviewing, and maintaining technical documentation.
• Knowledge of medical device regulations and applicable Food and Drug requirements.
• Strong understanding of ISO 13485 and quality management system processes.
• Experience evaluating compliance risks and making compliance-based decisions.
• Ability to build cross-functional relationships and influence stakeholders across multiple functions.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).