Quality Systems Specialist

We anticipate the application window for this opening will close on - 5 Nov 2026

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

At Medtronic, you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

The Quality Specialist supports Quality Management System (QMS) execution and quality operations within the Woolwich Distribution Center, ensuring compliance with regulatory requirements, internal quality standards, and Medtronic quality system procedures. This role partners closely with Distribution Operations, Supply Chain, Engineering, Regulatory Affairs, and Quality leadership to support product flow, nonconforming product management, audit readiness, process improvement, and continuous quality initiatives that enable safe and compliant
distribution activities.

This position is based in Swedesboro, New Jersey and is fully onsite. Approximately 5% travel is required, primarily for training activities.

The Quality Specialist serves as a key quality partner to distribution operations, providing day-to-day support for quality systems, compliance activities, product disposition, investigations, audits, and continuous improvement initiatives. This role helps ensure products are managed in accordance with applicable regulatory requirements, internal procedures, and quality standards while supporting efficient distribution center operations.

Responsibilities may include the following and other duties may be assigned:

• Provide daily quality support to distribution operations and serve as a quality resource during operational escalations and issue resolution activities.
• Manage Product Hold Orders (PHOs), Return-to-Vendor (RTV) activities, product segregation processes, and disposition of nonconforming products.
• Support investigations, containment activities, root cause analysis, and corrective and preventive actions for quality issues.
• Maintain and support Quality Management System documentation, including Job Instruction Bulletins (JiBs), work instructions, and controlled documents.
• Participate in internal, external, and regulatory audit preparation, evidence collection, response activities, and follow-up actions.
• Conduct quality walk-throughs and Gemba activities to identify compliance risks and process improvement opportunities.
• Support calibration, environmental monitoring, validation activities, and reporting of quality-related excursions.
• Monitor quality metrics and contribute to continuous improvement initiatives focused on compliance, risk reduction, and operational performance.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

• Bachelor's degree and 2+ years of experience in Quality, Manufacturing, Distribution, Supply Chain, or regulated industry environments OR Master's degree and 0 years of experience.

Nice to Have

• Experience supporting Quality Management System (QMS) processes.
• Experience investigating nonconforming products, quality events, or corrective and preventive action activities.
• Experience supporting audits, compliance programs, or regulated quality processes.
• Experience working with controlled documentation, procedures, or change control processes.
• Experience in medical device, pharmaceutical, biotechnology, or other regulated industries.
• Experience with Product Hold Orders (PHOs), Return-to-Vendor (RTV) processes, or product disposition activities.
• Experience with Corrective and Preventive Action (CAPA) and Supplier Corrective and Preventive Action (SCAPA) processes.
• Experience supporting calibration, environmental monitoring, or validation activities.
• Experience applying continuous improvement methodologies within distribution, warehouse, or manufacturing operations.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

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.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. …