Quality System Specialist

Job Description

Job Title - Sr Quality Systems Spec - Exempt

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Job Location - Onsite Tempe, Arizona, 85281-5132

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Duration: 12 Months

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HM's Top Needs:

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

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2. SAP-based order and shipment execution

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Customer complaint/RMA and cross-functional coordination experience

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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.

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

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• Customer-Focused Quality Systems and Process Ownership
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• Optimize and enhance existing Tempe frameworks that support customer-related activities to ensure alignment with ISO 13485, FDA requirements, and internal quality system standards.
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• Establish, track, and continuously improve metrics and measurable indicators for customer-related processes (e.g., order performance, complaints, returns, turnaround times, service quality).
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• Create, maintain, and revise QMS documentation (procedures, work instructions, forms, templates) required to support customer-related processes.
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• Ensure audit readiness for customer-related quality processes and act as the subject matter expert (SME) during internal, external, and regulatory audits.
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• Work with cross-functional and quality teams to develop, implement, and refine methods for collecting and reporting customer feedback and quality data.
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• Customer Interface and Order Management
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• 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.
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• Work with local planning team to accept forecasts and purchase orders from customers and create corresponding sales orders in SAP.
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• Provide clear order acknowledgements to customers, leveraging SAP functionality where available and supporting configuration needs for the site as appropriate.
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• Collaborate with Planning to obtain and confirm commit dates and communicate commitments to customers.
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• 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.
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• Ensure SAP shipment transactions are completed accurately to generate invoices and shipping paperwork required by customers.
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• Change Management and Customer Portals
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• Partner with Engineering and other internal stakeholders to understand and execute customer-requested changes (e.g., product, documentation, process, or configuration changes).
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• Submit and manage changes through customer change portals, acting as a liaison to reduce administrative burden on Engineering and other technical teams.
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• Ensure customer change requirements are accurately translated into internal actions, documented in the QMS, and reflected in relevant systems.
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• Complaints, Returns, and Issue Resolution
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• Field customer complaints, feedback, and requests for Return Material Authorization (RMA), ensuring timely triage, documentation, and routing within the quality system.
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• Coordinate with Quality, Operations, Engineering, and other teams to investigate issues, drive corrective actions, and improve service quality.
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• Provide regular status updates to customers on open issues, complaints, and RMAs, ensuring a high level of transparency and responsiveness.
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• Cross-Functional Collaboration and Reporting
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• Develop and maintain strong working relationships with internal stakeholders (Quality, Engineering, Planning, Operations, Finance, Commercial teams) to resolve issues and drive process improvements.
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• Track and report progress against objectives for customer-related quality initiatives, providing in-depth analysis and recommendations for process improvements.
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• Work with Finance to provide accurate billable hour and cost information and support other customer-related financial tasks as needed.
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Nice to Have:

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• Experience with SAP (sales order creation, shipment transactions, and/or customer-related configuration).
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• Familiarity with ISO 13485 and FDA quality system requirements.
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• Experience with complaint handling, RMAs, or customer feedback systems.
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• Prior experience in a role interfacing with Planning, Engineering, Operations, and Finance to support customer commitments and quality outcomes.
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• Strong analytical skills with the ability to define, track, and interpret metrics for customer-related processes.
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• Excellent communication skills and proven ability to collaborate with senior internal and external stakeholders.
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Education Required:

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• Requires a Baccalaureate degree
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Years’ Experience Required:

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

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