Quality Supervisor Visa Sponsorship Jobs in Illinois

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
• SOP-00048

• FDA reportability guidance

• 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, 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

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