Medical Device Quality And Compliance Specialist

About the role

This is a hybrid position based out of Mettawa, IL. The schedule includes working from home on Monday and Friday, with in-office work Tuesday, Wednesday, and Thursday.

Required experience

• 1+ year of experience in any of the following areas: complaint handling, MDR reportability assessments, post-market surveillance, CAPA support, audit readiness, risk-based documentation, and cross-functional collaboration across Quality, Regulatory Affairs, Clinical, R&D, Operations, and business stakeholders
• Practical exposure to FDA medical device reporting expectations, 21 CFR Part 803, complaint-handling requirements, quality-system documentation, eMDR/FDA reporting workflows, regulatory decision rationale, and audit-ready records

Required skills

• Strong technical writing, analytical thinking, attention to detail, prioritization, organization, documentation accuracy, project coordination, and ability to manage multiple deadlines in a regulated environment
• Ability to interpret technical product information and translate it into regulatory decisions or documentation
• Proficiency with Microsoft Office / Excel / Word / PowerPoint, regulatory databases, tracking tools, complaint systems, SAP, TrackWise, ETQ Reliance, RIMS/Veeva Vault, FDA eSTAR, ESG/eMDR workflows, and GUDID/UDI-related systems where applicable

Pay

$35.00/hr

Benefits

• 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)

Schedule

This is a hybrid position: Monday and Friday work from home; Tuesday, Wednesday, and Thursday in office.