Quality Supervisor, MDR Remediation

Lead, manage, and develop a team

Establish clear roles, responsibilities, and performance expectations

Set and monitor daily and weekly output targets aligned to remediation timelines

Conduct routine performance assessments, including throughput, accuracy, and rework trends

Provide targeted, real-time feedback to drive quality and efficiency

Oversee end-to-end MDR remediation workflow, including:

• Reportability assessment
• Investigation and data gathering
• MDR preparation and submission

Ensure adherence to standardized workflows

Ensure adherence to standardized workflows, including a structured 4-phase remediation model

Ensure all MDR decisions align with: 21 CFR Part 803 o SOP-00048FDA reportability guidance

Review outputs and enforce standards

Review outputs for accuracy, completeness, and consistency with risk files and established criteria

Enforce standardized language justification for reportability decisions

Implement and maintain standardized processes

Implement and maintain standardized processes, templates, and tools

Train and support team

Serve as escalation point for complex or ambiguous cases

Partner with Clinical, Regulatory, and Quality teams to resolve issues and support decision making

Track and report key performance metrics, including throughput, timeliness, and quality trends

Provide regular updates on remediation progress, risks, and resource needs

Support audit readiness, CAPA effectiveness monitoring, and FDA inspection activities

Ensure team training completion, role qualification, and adherence to regulatory standards

Qualifications

• 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, Track Wise)
• 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