Senior Quality Systems Specialist

Senior Quality Systems SpecialistCareers 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.At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're 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 OwnershipOptimize 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 ManagementServe 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 PortalsPartner 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 ResolutionField 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 ReportingDevelop 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 RequirementsThe 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 & SponsorshipAt 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.Recruitment Fraud AlertWe are aware of phishing scams targeting job seekers. Please keep the following in mind:Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at View email address on click.appcast.io & CompensationMedtronic 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):$93,600.00 - $140,400.00This 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