About the role

  • Senior Quality Compliance Manager leading governance and improvement of Quality Management System at Medline. Overseeing QMS activities and ensuring regulatory compliance throughout product lifecycle.

Responsibilities

  • Provides senior‑level Quality leadership focused on the governance, execution, and continuous improvement of the Quality Management System (QMS)
  • Owns divisional QMS activities supporting post‑market surveillance, complaint handling and investigations, CAPA and SCAR management, supplier quality monitoring, risk management
  • Leads QMS execution across data monitoring, trending, and management review inputs
  • Drives corrective actions and systemic improvements through structured analysis of post‑market and supplier quality data
  • Establishes and maintains inspection‑ready QMS processes, procedures, and records
  • Sets operational priorities and oversees resource allocation for QMS activities
  • Partners cross‑functionally to ensure sustained compliance and effective system performance

Requirements

  • Bachelor’s degree in Engineering, Science, or Technical Field
  • At least 5 years of experience related to the design/operation of medical device or drug combination product platforms
  • At least 2 years of management experience
  • Depth of technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, MDR)
  • Proficiency in analyzing and reporting data and performing statistical analysis
  • Advanced skill level in Microsoft Excel
  • Position requires travel up to 30% of the time for business purposes

Benefits

  • health insurance
  • life and disability
  • 401(k) contributions
  • paid time off

Job title

Senior Quality Compliance Manager

Job type

Experience level

Senior

Salary

$134,000 - $201,000 per year

Degree requirement

Bachelor's Degree

Location requirements

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