Senior Analyst, Quality Compliance
Core
Strengthening the global Quality Management System through internal auditing, quality compliance, and continuous improvement activities.
Role type
Senior Quality Compliance Analyst
Builds
Global Quality Management System and regulatory readiness
Domain
Medical device manufacturing / Regulatory compliance
Required skills
Quality Assurance, Quality Systems, Auditing, Regulatory compliance, Corrective and Preventive Action (CAPA), Risk-based auditing, FDA QMSR, ISO 13485, MDSAP, 21 CFR 820, EU MDR, Data analytics
Preferred skills
Medical device industry experience, FDA/Notified Body inspection support, Lead Auditor certification (CQA), Six Sigma, Lean, Risk management principles
Technologies
Quality Management Systems, Audit tools, Data visualization tools
Responsibilities
Conduct compliance assessments, gap analyses, and quality system audits across sites and functions; Partner with stakeholders to manage audit findings and facilitate CAPAs; Analyze audit results and quality metrics to identify trends and risks; Support development of risk-based auditing strategies; Coordinate and support quality audits and regulatory inspections; Lead inspection readiness activities; Serve as a quality compliance subject matter expert
Seniority
Senior, hands-on IC