Quality Manager

QMS | Quality Manager We are seeking a Quality Manager to lead the development, implementation, and continuous improvement of an enterprise Quality Management System (QMS). This individual will partner across Product, Engineering, Operations, and Customer teams to establish scalable quality processes, ensure regulatory compliance, and promote a culture of quality throughout the organization. This is a highly visible role with the opportunity to build and mature the quality function over time. Key Responsibilities Lead the strategy, governance, and continuous improvement of the Quality Management System (QMS) Drive adoption of quality standards, processes, and best practices across the organization Manage document control, training, change management, CAPA, supplier management, audits, and management reviews Support software and hardware validation activities, including Computer Systems Validation (CSV) Develop quality metrics, KPIs, and reporting to measure performance and compliance Facilitate internal and external audits and ensure effective corrective actions Partner with cross‑functional teams to embed quality throughout the product development lifecycle Promote a culture of continuous improvement, operational excellence, and risk management Evaluate and support implementation of electronic Quality Management Systems (eQMS) Required Qualifications Bachelor's degree in Quality, Engineering, Life Sciences, Operations, Business, or related field 5+ years of experience leading Quality Assurance or Quality Management initiatives Experience managing and maintaining an ISO 9001‑compliant Quality Management System Strong understanding of Software Development Lifecycle (SDLC) and Agile methodologies Experience with Computer Systems Validation (CSV) Experience validating software and/or hardware products in regulated environments Knowledge of document control, CAPA, audits, training, supplier management, and change control processes Strong leadership, communication, and stakeholder management skills Preferred Qualifications Experience implementing or managing an eQMS platform Knowledge of ISO 9001, 21 CFR Part 11, EU Annex 11, GxP, and ISO/IEC 17025 standards Experience in SaaS, technology, life sciences, biotech, medical device, or regulated environments Experience building quality programs and driving organizational change Additional Information Remote or hybrid work environment Limited travel requiredOpportunity to shape and scale the quality function as the organization grows #J-18808-Ljbffr