Sr. Quality Management System Specialist
Core
Design, maintain, and continuously improve a quality management system to support regulatory approval and business growth for global medical device markets.
Role type
Senior Quality Management System Specialist
Builds
Compliant quality management systems aligned with global medical device regulations
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality system documentation, Internal Quality Agreements, Supplier Quality Agreements, Mergers and Acquisitions QMS activities, regulatory compliance assessment, process optimization, audit preparation and response, training content development
Preferred skills
U.S. and international medical device regulatory knowledge, audit and management review support, quality planning, corrective action processes, regulated information systems change control, good manufacturing and distribution practices
Responsibilities
Support and maintain a compliant Quality Management System aligned with global medical device regulations; Develop and update quality system processes, procedures, and documentation; Assess and quantify quality system requirements to optimize structure, integration, and scalability; Identify and implement continuous improvement opportunities; Support management review, quality planning forums, and governance activities; Partner with stakeholders to ensure quality processes reflect operational activities; Prepare for and support internal, external, and third-party quality system audits; Contribute to quality system training content and delivery
Seniority
Senior, hands-on IC
