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.
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
•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.
U.S. Work Authorization & Sponsorship
U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package.
Salary ranges for U.S (excl. PR) locations (USD): $75,200.00 - $112,800.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
