Senior Quality Systems Specialist

We anticipate the application window for this opening will close on - 19 Jun 2026

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

At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. Were working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

The Senior Quality Systems Specialist will serve as the primary interface between Medtronic and external customers for a designated business while owning and optimizing the Quality Management System (QMS) processes that support customer-related activities. This role combines hands-on customer support (orders changes complaints RMAs) with end-to-end responsibility for designing maintaining and improving quality processes metrics and documentation in alignment with ISO 13485 and FDA requirements.

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

• Customer-Focused Quality Systems and Process Ownership

• Optimize and enhance existing Tempe Medtronic frameworks that support customer-related activities to ensure alignment with ISO 13485 FDA requirements and internal quality system standards.

• Establish track and continuously improve metrics and measurable indicators for customer-related processes (e.g. order performance complaints returns turnaround times service quality).

• Create maintain and revise QMS documentation (procedures work instructions forms templates) required to support customer-related processes.

• Ensure audit readiness for customer-related quality processes and act as the subject matter expert (SME) during internal external and regulatory audits.

• Work with cross-functional and quality teams to develop implement and refine methods for collecting and reporting customer feedback and quality data.

• Customer Interface and Order Management

• Serve as the primary point of contact for assigned external customers working with local groups on coordinating orders changes issue resolution feedback/complaints returns and requests.

• Work with local planning team to accept forecasts and purchase orders from customers and create corresponding sales orders in SAP.

• Provide clear order acknowledgements to customers leveraging SAP functionality where available and supporting configuration needs for the site as appropriate.

• Collaborate with Planning to obtain and confirm commit dates and communicate commitments to customers.

• Monitor drop shipments and coordinate with Planning to define transaction ownership (Planning vs. this role) in MES and SAP to ensure accurate shipment execution and documentation.

• Ensure SAP shipment transactions are completed accurately to generate invoices and shipping paperwork required by customers.

• Change Management and Customer Portals

• Partner with Engineering and other internal stakeholders to understand and execute customer-requested changes (e.g. product documentation process or configuration changes).

• Submit and manage changes through customer change portals acting as a liaison to reduce administrative burden on Engineering and other technical teams.

• Ensure customer change requirements are accurately translated into internal actions documented in the QMS and reflected in relevant systems.

• Complaints Returns and Issue Resolution

• Field customer complaints feedback and requests for Return Material Authorization (RMA) ensuring timely triage documentation and routing within the quality system.

• Coordinate with Quality Operations Engineering and other teams to investigate issues drive corrective actions and improve service quality.

• Provide regular status updates to customers on open issues complaints and RMAs ensuring a high level of transparency and responsiveness.

• Cross-Functional Collaboration and Reporting

• Develop and maintain strong working relationships with internal stakeholders (Quality Engineering Planning Operations Finance Commercial teams) to resolve issues and drive process improvements.

• Track and report progress against objectives for customer-related quality initiatives providing in-depth analysis and recommendations for process improvements.

• Work with Finance to provide accurate billable hour and cost information and support other customer-related financial tasks as needed.

Required Knowledge and Experience:

• Requires a Baccalaureate degree (or for degrees earned outside of the United States a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A)

• A minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience.

Nice to Have:

• Experience with SAP (sales order creation shipment transactions and/or customer-related configuration).

• Familiarity with ISO 13485 and FDA quality system requirements.

• Experience with complaint handling RMAs or customer feedback systems.

• Prior experience in a role interfacing with Planning Engineering Operations and Finance to support customer commitments and quality outcomes.

• Strong analytical skills with the ability to define track and interpret metrics for customer-related processes.

• Excellent communication skills and proven ability to collaborate with senior internal and external stakeholders.

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 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.

Join us in our mission to alleviate pain restore health and extend lifewhere your unique background and perspective are valued.

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.

Salary ranges for U.S (excl. PR) locations (USD):$93600.00 - $140400.00

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 insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

Learn more about our business mission and our commitment to diversity here.

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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.