Quality Supervisor

Basic Qualifications
• Bachelor's degree in a scientific, engineering, or related field
• Minimum of 5 years of experience in medical device complaint handling, MDR reporting, or regulatory compliance
• Minimum of 2 years of direct people management experience
• Strong knowledge of 21 CFR Part 803 and MDR requirements
• Experience with complaint handling systems (e.g., ETQ Reliance, TrackWise)
• Experience supporting FDA inspections and CAPA activities

Preferred Qualifications
• Experience leading MDR remediation or retrospective review programs
• Familiarity with FDA eMDR submission processes
• Experience with FDA device, patient, and evaluation coding
• Knowledge of risk management and CAPA integration
• Experience building or optimizing high-volume workflows

Core Competencies
• Leadership and performance management
• Audit readiness and attention to detail
• Regulatory decision-making in complex scenarios
• Process improvement and standardization
• Cross-functional communication and collaboration

Work Environment / Expectations
• Fast-paced, high-volume regulatory remediation environment
• Requires strong prioritization, organization, and decision-making skills
• Ability to manage multiple workstreams and deadlines simultaneously