Senior Quality Systems Specialist

Key Responsibilities

Customer Support & SAP Order Management

·         Serve as the primary contact for assigned external customers.

·         Coordinate customer orders, forecasts, purchase orders, changes, complaints, returns, and requests.

·         Create sales orders in SAP based on customer purchase orders and forecasts.

·         Provide order acknowledgements and confirm delivery commitments with Planning.

·         Monitor drop shipments and coordinate transaction ownership across MES and SAP.

·         Ensure accurate shipment transactions, invoices, and customer shipping documentation.

·         Work with Finance to provide accurate billable-hour and cost information.

Quality Systems & Regulatory Compliance

·         Maintain and improve customer-related Quality Management System (QMS) processes.

·         Create, maintain, and revise quality procedures, work instructions, forms, and templates.

·         Ensure compliance with ISO 13485, FDA requirements, and internal quality standards.

·         Develop and track metrics for 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.

·         Support corrective and preventive actions (CAPA), audit findings, and quality documentation.

·         Interpret applicable regulatory requirements and provide guidance to stakeholders.

Change Management

·         Coordinate customer-requested product, documentation, process, and configuration changes.

·         Submit and manage changes through customer portals.

·         Partner with Engineering and other stakeholders to translate customer requirements into internal actions.

·         Ensure changes are properly documented in the QMS and relevant systems.

Complaints, Returns & Issue Resolution

·         Manage customer complaints, feedback, and Return Material Authorization (RMA) requests.

·         Ensure timely triage, documentation, investigation, and routing through the quality system.

·         Coordinate with Quality, Operations, Engineering, Planning, and other teams to resolve issues.

·         Provide customers with regular status updates on open complaints, returns, and corrective actions.

·         Analyze customer-related quality data and recommend process improvements.

Process Improvement & Project Management

·         Analyze existing processes and identify opportunities to improve efficiency and quality.

·         Develop metrics, monitor performance, and report progress against objectives.

·         Lead or coordinate quality-related projects from design through implementation.

·         Support consistent global quality standards and best-practice sharing.

·         Build relationships and consensus across teams to achieve business objectives.

·         Provide guidance, coaching, and mentoring to lower-level specialists when required.

·         Work independently under limited supervision to resolve complex process and quality issues.