Quality Systems Specialist

Medtronic • Swedesboro, NJ

8d • Onsite

About The Position

The Quality Specialist supports Quality Management System (QMS) execution and quality operations within Medtronic’s Woolwich Distribution Center. The role ensures compliance with regulatory requirements, internal quality standards, and Medtronic quality system procedures, and partners 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.

Based in Swedesboro, New Jersey, this position is fully onsite and requires approximately 5% travel, primarily for training. The Quality Specialist provides day-to-day quality support to distribution operations, including quality systems, compliance activities, product disposition, investigations, audits, and continuous improvement. The role helps ensure products are handled in accordance with applicable regulatory requirements, internal procedures, and quality standards while supporting efficient distribution center operations. Other duties may be assigned.

Medtronic describes itself as a global healthcare technology leader with approximately 95,000 employees in more than 150 countries. Its mission is to alleviate pain, restore health, and extend life. The position is eligible for the Medtronic Incentive Plan, and the advertised U.S. salary range is $75,200–$112,800. Benefits listed for eligible regular employees include insurance coverage, retirement plans, paid time off, paid holidays, tuition assistance, an employee stock purchase plan, and well-being resources, subject to the stated eligibility conditions.

Requirements

• Bachelor's degree and 2 or more years of experience in Quality, Manufacturing, Distribution, Supply Chain, or regulated industry environments, or a master's degree and no experience.
• For baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
• Roles below Principal level require unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

• 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.

Responsibilities

• Provide daily quality support to distribution operations and serve as a quality resource during operational escalations and issue resolution.
• 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.

Benefits

• Competitive salary and flexible benefits package.
• Medtronic Incentive Plan (short-term incentive).
• Health insurance.
• Dental insurance.
• Vision insurance.
• Health Savings Account.
• Healthcare Flexible Spending Account.
• Life insurance.
• Long-term disability leave.
• Dependent daycare spending account.
• Tuition assistance/reimbursement.
• Simple Steps global well-being program.
• 401(k) plan with 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.
• Capital Accumulation Plan, available to Vice Presidents and above or subject to IRS earning minimums.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level