Senior Quality Systems Specialist

Position Overview 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 Customer‑Focused Quality Systems and Process Ownership: Optimize and enhance existing 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 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. 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. 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. 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. 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 that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A)). Minimum of 4 years of relevant experience, or an 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. Physical Job Requirements The position requires regular independent mobile activity, computer interaction, and communication with peers and co‑workers. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Benefits & Compensation Salary range (U.S., excluding Puerto Rico): $93,600.00 – $140,400.00. Additional benefits include Health, Dental, Vision insurance, Health Savings Account, Flexible Spending Account, Life insurance, Long‑term disability leave, Dependent daycare spending account, Tuition assistance, 401(k) plan with employer match, Short‑term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, and other incentive plans. Additional compensation may include the Medtronic Incentive Plan. EEO Statement Medtronic is an equal opportunity employer and will not discriminate on the basis of age, color, national origin, citizenship status, disability, race, religion, creed, gender, sex, sexual orientation, gender identity, or any other characteristic protected by federal, state, or local law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities. #J-18808-Ljbffr Medtronic