Quality System Specialist

1. Customer-facing quality systems experience in a regulated environment

2. SAP-based order and shipment execution

The Senior Quality Systems Specialist will serve as the primary interface between Org 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 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.

• 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…