Quality Specialist
CatapultAt SATO America, LLC, our mission is to create new value for our customers through products and services of superior quality and to contribute toward a better and more sustainable world. For more than 80 years, SATO has fostered a culture of professionalism and customer-centric innovation with an unchanging mission of creating value for customers that, in turn, contributes to a more sustainable world. This is a full-time, permanent position at SATO America. Job title: Quality Specialist Onsite position Job Location: Charlotte, NC, 28273, United States SUMMARY: The QA Specialist role is an onsite role based in Charlotte, North Carolina. In this role as QA Specialist at SATO America, you would be supporting and maintaining the Quality Management System (QMS) in alignment with the company's all certification programs. This role ensures compliance with regulatory requirements, and other guidelines such as cGMP, Underwriters Laboratory (UL), Forest Stewardship Council (FSC) based on business and customer needs, while fostering a strong Quality Culture and Safety Culture across the organization. You play a key role in non-conformance management, auditing, support for supplier quality oversight, document control, and continuous improvement initiatives. The organization is committed to operational excellence through a robust ISO 9001 Quality Management System and a proactive Environmental, HealthSafety (EHS) program that emphasizes accountability, prevention, and continuous improvement. TRAVEL REQUIREMENTS: 25-50% or as needed KEY RESPONSIBILITIES: Non-Conformance Management Manage and document non-conformances, deviations, CAPA's, and quality events in accordance with ISO 9001 QMS requirements. Lead investigations to determine root cause and implement corrective and preventive actions (CAPA). Track, trend, and analyze non-conformance data to identify systemic issues. Ensure timely closure and effectiveness verification of CAPAs. RegulatoryCompliance Ensure compliance with applicable regulatory standards (REACH, RoHS etc.), cGMP, ICH guidelines, and ISO 9001 requirements. Support regulatory requests. Maintain inspection and audit readiness at all times. Support external regulatory inspections (UL, FSC etc.) and customer audits. Promote adherence to standardized processes and continuous improvement principles consistent with ISO 9001. cGMP Compliance Auditor Conduct audits to ensure compliance with current Good Manufacturing Practices (cGMP) and ICH guidelines. Identify compliance gaps and recommend corrective actions. Prepare audit reports and ensure timely follow-up on findings. Internal Auditor Plan and execute internal audits across departments in accordance with ISO 9001 QMS. Evaluate effectiveness of quality systems and process controls. Support management review and continuous improvement activities. Supplier Quality Audits (as Needed) Conduct supplier qualification and periodic audits as required. Collaborate with Procurement and Operations to ensure supplier compliance. Attend Supplier QA meetings and provide quality oversight. Supports Customer Feedback (CF) Assist in responding to customer quality inquiries, complaints, and corrective actions. Support customer audits and quality-related communications. Partner with Customer Feedback (CF) teams to ensure high levels of customer satisfaction and compliance. Document Control Maintain controlled documents in accordance with ISO 9001 QMS standards. Create, review, approve, distribute, and archive SOPs, work instructions, and quality records. Ensure document traceability and revision control. Support electronic document management systems (EDMS). Quality Training Program Support Support implementation and maintenance of the Quality Training Program. Provide quality training as needed or requested for employees. Maintain accurate training records and competency documentation. Assist in development of training materials and facilitate sessions as needed. Cross-Functional Engagement …