Senior Quality Systems Specialist

A Senior Quality Systems Specialist is sought to serve as the primary interface between the organisation and external customers, focusing on customer-facing quality systems within a regulated environment. The role is based onsite in Tempe, AZ, and requires full-time attendance.

The specialist will manage and optimise quality management system (QMS) processes supporting customer-related activities, ensuring compliance with ISO 13485, FDA requirements, and internal standards. Responsibilities include establishing and tracking metrics for customer processes such as order performance, complaints, returns, and service quality. The role involves creating, maintaining, and revising QMS documentation, and ensuring audit readiness for customer-related quality processes.

Key duties include acting as the main point of contact for assigned customers, coordinating orders, changes, complaints, and returns. The specialist will work with the planning team to process forecasts and purchase orders, create sales orders in SAP, and provide order acknowledgements. Accurate execution of shipment transactions in SAP is required to generate invoices and shipping paperwork.

The position also partners with engineering and internal stakeholders to execute customer-requested changes and manages submissions through customer change portals. Handling customer complaints and RMAs, coordinating investigations, and providing regular status updates to customers are integral to the role.

Collaboration across quality, engineering, operations, finance, and commercial teams is essential to resolve issues and drive process improvements. The specialist will track and report progress on customer-related quality initiatives, offering analysis and recommendations.

Candidates must hold a baccalaureate degree and have a minimum of four years of relevant experience, or an advanced degree with at least two years of relevant experience. Experience with SAP, ISO 13485, FDA requirements, and customer complaint handling is highly desirable. Strong analytical and communication skills, as well as the ability to collaborate with senior stakeholders, are required.

• SAP
• Quality Management System
• ISO 13485
• FDA requirements
• Customer complaint handling
• Return Material Authorization

• Customer feedback systems
• Cross-functional coordination
• Analytical
• Project management

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as:

• health insurance
• health savings accounts
• retirement savings plans
• life and disability insurance
• paid leave where required by applicable law

Eligibility may vary based on factors such as location and hire date and is subject to change.