Job Description
Quality Assurance Supervisor (MDR) at Dexian Quality Assurance Supervisor (MDR) at Dexian in Wauconda, Illinois Posted in about 19 hours ago.
Type:
full-time Job Description:
The Supervisor, MDR Remediation, leads a high-volume team responsible for retrospective Medical Device Reporting (MDR) in response to FDA 483 observations. This role oversees 20-25 employees across screening, investigation, and submission functions, ensuring timely, compliant, and audit-ready MDR determinations aligned with 21 CFR Part 803 and internal SOPs. KEY RESPONSIBILITIES
Team Leadership & Performance Lead, coach, and develop a team of 20-25 employees Define roles, expectations, and performance standards Monitor productivity, accuracy, and rework trends Deliver real-time feedback to improve quality and throughput MDR Remediation Execution Oversee end-to-end MDR workflow: Reportability assessment Investigation and data collection MDR preparation and submission Ensure alignment with 21 CFR Part 803, SOP-00048, and FDA guidance Enforce consistent, defensible reportability decisions Process Standardization & Quality Implement standardized workflows, templates, and tools (including 4-phase remediation model) Ensure consistent use of malfunction matrices and MDR conventions Review outputs for accuracy, completeness, and alignment with risk files Serve as an escalation point for complex cases Cross-Functional Collaboration Partner with Clinical, Regulatory, and Quality teams Resolve ambiguous cases and support regulatory decision-making Metrics, Reporting & Compliance Track and report throughput, timeliness, and quality metrics Provide updates on progress, risks, and resource needs Support audit readiness, CAPA effectiveness, and FDA inspections Ensure training completion and regulatory compliance across the team QUALIFICATIONS
Required Bachelor's degree (science, engineering, or related) 5+ years in medical device complaint handling, MDR, or regulatory compliance 2+ years of people management experience Strong knowledge of 21 CFR Part 803 Experience with complaint systems (e.g., ETQ, TrackWise) Experience supporting FDA inspections and CAPA Preferred MDR remediation or retrospective review experience eMDR submission familiarity Knowledge of FDA coding conventions Experience with risk management and CAPA integration High-volume workflow optimization experience Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
