Medical Device Quality And Compliance Specialist

Contract position based in Vernon Hills, IL. Hybrid work environment within a large medical device company, offering a dynamic, fast-paced team setting with tight deadlines.

About the role

As a Medical Device Quality and Compliance Specialist, you will handle complaints, conduct MDR reportability assessments, support post-market surveillance, ensure audit readiness, and manage risk-based documentation. You will collaborate cross-functionally with teams in Quality, Regulatory Affairs, Clinical, R&D, Operations, and other business stakeholders.

Responsibilities

• Handle and assess complaints related to medical devices.
• Conduct MDR reportability assessments and support post-market surveillance activities.
• Ensure audit readiness and manage risk-based documentation effectively.
• Collaborate with cross-functional teams including Quality, Regulatory Affairs, Clinical, R&D, Operations, and business stakeholders.
• Maintain audit-ready records and ensure compliance with FDA medical device reporting expectations and 21 CFR Part 803.

Requirements

• Experience in medical device quality assurance and regulatory compliance.
• Strong technical writing skills and ability to create quality-system documentation.
• Proficiency in audit, technical writing, corrective action plans, and complaint handling.
• Familiarity with eMDR/FDA reporting workflows and regulatory decision-making.
• Ability to interpret and translate technical, scientific, complaint, and product information.

Skills

• Proficiency with Microsoft Office Suite, including Excel, Word, and PowerPoint.
• Experience with regulatory databases, tracking tools, complaint systems, SAP, TrackWise, and FDA eSTAR.
• Ability to manage multiple deadlines in a regulated environment.
• Strong analytical thinking, attention to detail, and organizational skills.

Pay

$35.00 - $35.00/hr.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may include:

• Medical, dental, and vision insurance.
• Critical Illness, Accident, and Hospital coverage.
• 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).