Quality Supervisor, MDR Remediation

Job description:

• Lead, manage, and develop a team of 20 25 employees across screening, investigation, and MDR submission functions.
• 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, including a structured 4-phase remediation model.
• Ensure all MDR decisions align with:
• 21 CFR Part 803 o SOP-00048.
• FDA reportability guidance.
• Review outputs for accuracy, completeness, and consistency with risk files and established criteri.
• Enforce standardized language justification for reportability decisions.
• Implement and maintain standardized processes, templates, and tools.
• Ensure consistent use of malfunction matrices and MDR numbering conventions.
• 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.

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.