Responsible for managing customer-facing quality systems, SAP-based order and shipment execution, customer complaints, and Return Material Authorizations (RMAs) while maintaining compliance with

ISO 13485, FDA

regulations, and medical device quality standards. Job Requirements Experience managing customer-facing quality systems within the medical device industry or a similarly regulated manufacturing environment. Experience with SAP-based sales order processing, shipment transactions, and order management. Experience handling customer complaints, Return Material Authorizations (RMAs), and quality issue resolution. Knowledge of Quality Management Systems (QMS) and regulatory compliance requirements. Understanding of ISO 13485 and FDA quality system requirements. Experience developing, maintaining, and improving quality system processes and documentation. Experience with customer order management, purchase orders, forecasts, and shipment processing. Knowledge of quality metrics, process monitoring, and continuous improvement methodologies. Experience supporting internal, external, and regulatory quality audits. Experience coordinating quality activities across Engineering, Planning, Operations, Quality, and Finance. Preferred Skills Advanced SAP experience, including sales order creation, shipment execution, and customer-related system configuration. Experience with Manufacturing Execution Systems (MES). Experience managing customer change requests through customer portals. Knowledge of medical device complaint handling and regulatory reporting processes. Experience with corrective and preventive action (CAPA) processes. Familiarity with document control, change management, and quality system optimization. Experience developing customer quality metrics related to order performance, complaints, returns, and turnaround times. Job Responsibilities Manage and optimize customer-facing Quality Management System (QMS) processes in accordance with

ISO 13485, FDA

regulations, and internal quality standards. Serve as the primary contact for assigned external customers regarding orders, changes, complaints, returns, and quality-related requests. Develop, revise, and maintain QMS documentation, including procedures, work instructions, forms, and templates. Establish, monitor, and improve customer quality metrics, including order performance, complaints, returns, turnaround times, and service quality. Maintain audit readiness and serve as a subject matter expert during internal, external, and regulatory audits. Develop and improve processes for collecting, analyzing, and reporting customer feedback and quality data. Process customer forecasts and purchase orders and create corresponding sales orders in SAP. Generate order acknowledgments and coordinate delivery commitments with Planning. Monitor drop shipments and coordinate MES and SAP transactions to ensure accurate shipment execution and documentation. Complete SAP shipment transactions and generate required invoices and shipping documentation. Manage customer-requested product, process, documentation, and configuration changes. Submit, track, and process customer change requests through designated customer portals. Ensure customer change requirements are documented within the QMS and incorporated into applicable internal systems. Receive, document, and process customer complaints, feedback, and Return Material Authorization (RMA) requests. Coordinate investigations and corrective actions related to customer quality issues. Maintain records and provide status updates on open complaints, returns, and customer issues. Support quality system improvements involving Planning, Engineering, Operations, Quality, and Finance. Ensure customer-related quality activities comply with applicable regulatory requirements and established quality procedures.

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for

Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.