Quality Supervisor - MDR Remediation

Job Description:

Quality Leader - MDR Remediation The Quality Leader for MDR Remediation manages a high-volume team to support retrospective Medical Device Reporting (MDR) activities in response to FDA observations. This role oversees 20-25 direct reports across multiple functions, ensuring timely, compliant, and audit-ready MDR determinations and submissions per regulatory standards. Responsibilities 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 regulatory standards and internal procedures. 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. Essential Skills 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, such as TrackWise. Experience supporting FDA inspections and CAPA activities. Additional Skills & Qualifications Bachelor's degree in a scientific, engineering, or related field. 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. Job Type & Location This is a Contract position based out of Libertyville, IL. Pay and Benefits The pay range for this position is $40.00 - $43.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Libertyville,IL.

Application Deadline This position is anticipated to close on Jun 1, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.