Quality Supervisor- Medical Device

Quality Leader – MDR Remediation

Leads a team of 20–25 handling high‑volume MDR remediation work in response to FDA findings. Oversees complaint reviews, investigations, and MDR submissions to ensure compliance with 21 CFR Part 803 and internal procedures. Drives consistent decision‑making, improves processes, and ensures audit readiness.

Key Responsibilities

• Manage and develop a cross‑functional team (screening, investigation, submissions)
• Oversee end‑to‑end MDR remediation activities
• Ensure accurate, compliant, and timely MDR decisions and submissions
• Track team performance (quality, throughput, timeliness) and improve efficiency
• Standardize processes, templates, and reporting practices
• Act as escalation point for complex regulatory cases
• Partner with Clinical, Regulatory, and Quality teams
• Support audits, FDA inspections, and CAPA activities

Key Requirements

• 5 years in MDR, complaint handling, or regulatory compliance
• 2 years of people leadership experience
• Strong knowledge of 21 CFR Part 803
• Experience with QMS tools (e.g., TrackWise)
• Background in FDA inspections and CAPA
• Strong leadership, decision‑making, and organizational skills

This is a Contract position based out of Libertyville, IL.

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)

This is a hybrid position in Libertyville,IL.

This position is anticipated to close on Jun 3, 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.

Salary : $40 - $43