Quality Systems Specialist

MED Medtronic Inc; Swedesboro (NJ); On-site; USD 75,000 - 113,000; Full time

Benefits offered by this job

Health, Dental and Vision insurance

401(k) with employer match

Tuition assistance

Employee stock purchase plan

Paid time off

Job summary

Medtronic plc in Swedesboro, New Jersey, is seeking a Quality Specialist to support QMS execution at the Woolwich Distribution Center. The role focuses on product flow, nonconforming product management, audits, and continuous quality improvement in a fully onsite setting with about 5% travel.

You will partner with Distribution Operations, Supply Chain, Engineering, Regulatory Affairs, and Quality leadership to ensure compliance with regulatory requirements and internal procedures.

Qualifications

• Bachelor’s degree or higher in a relevant field with 2+ years of experience in quality, manufacturing, distribution, supply chain, or regulated environments.
• Experience supporting Quality Management System (QMS) processes.
• Experience investigating nonconforming products, quality events, or CAPA/SCAPA 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.

Responsibilities

• Provide daily quality support to distribution operations and act as a quality resource during escalations and issue resolution.
• Manage Product Hold Orders (PHOs), RTV activities, product segregation, and disposition of nonconforming products.
• Support investigations, containment, root cause analysis, and corrective/preventive actions for quality issues.
• Maintain QMS documentation and controlled documents (JIbs, work instructions).
• Participate in internal/external/regulatory audit preparation and evidence collection.
• Conduct quality walk-throughs and Gemba activities to identify compliance risks and improvement opportunities.

Skills

Quality systems experience

Regulated industry experience

CAPA/SCAPA experience

Audit support experience

Documentation control

Education

Bachelor’s degree in relevant field

Job description

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

• 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.
• 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.

Nice to Have Experience

• 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 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co‑workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise‑wide workforce planning approach, 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

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. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). 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
• 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)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans.

Equal Employment Opportunity

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Sales and Field Employees

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

E-Verify

This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E‑Verify program, please click here.

Additional Information

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