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Imricor Medical Systems Logo Imricor Medical Systems · Quality Control

Quality Systems Manager

United States, Burnsville Employment contract 130000.00 - 165000.00 USD / Year · Job Posted May 29, 2026
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Job Responsibility

  • Owns, maintains, and improves the Quality Management System in compliance with 21 CFR Part 820, EU MDR, ISO 13485, and other applicable international regulations and guidelines
  • Ensures effective implementation and ongoing compliance with QMS processes, procedures, and records
  • Owns and maintains electronic QMS system
  • Manages document control, record retention, and change control processes
  • Drives harmonization and simplification of quality documentation where possible
  • Owns and maintains external document and standards database and drive updates, as applicable
  • Plans, conducts, and manages internal audits and support external regulatory and customer audits
  • Acts as the primary interface with regulatory authorities and notified bodies during inspections
  • Leads audit responses, root cause analysis, and corrective actions to closure
  • Oversees the Corrective and Preventive Action (CAPA) system, ensuring timely, effective investigations and actions
  • Analyzes quality data and trends to proactively drive system improvements
  • Owns and maintains the Complaint Handling System in compliance with 21 CFR 820.198 and ISO 13485
  • Ensures timely intake, documentation, investigation, and closure of product complaints
  • Collaborates with Regulatory Affairs to ensure compliance with regulatory reporting and international vigilance requirements
  • Monitors complaint trends to identify systemic issues and drive continuous improvement
  • Leads and maintains Post‑Market Surveillance (PMS) processes in accordance with applicable U.S., EU MDR, and other applicable international regulations
  • Collects, analyzes, and evaluates post‑market data and prepare post-market reports (PMSR, PSURs)
  • Partners with cross‑functional teams to assess post‑market risk and ensure timely implementation of field actions when required
  • Defines, implements, and maintains quality metrics to monitor QMS performance and effectiveness
  • Prepares and presents quality performance reports to leadership and Management Review forums
  • Uses data-driven insights to identify risks, improvement opportunities, and systemic trends
  • Ensures QMS training programs are effective and current
  • Promotes a culture of quality, compliance, and continuous improvement across the organization
  • Performs other related duties and responsibilities, as assigned

Requirements

  • Bachelor of Science in a scientific discipline or equivalent education/training
  • 10+ years’ experience in Quality Systems
  • 4+ years within the medical device industry
  • Comprehensive working knowledge of EU MDR, ISO 13485, 21 CFR 820
  • Experience leading audits, CAPA systems, and regulatory inspections
  • Proven ability to effectively influence cross-functional teams

What we offer

  • Medical
  • Dental
  • Vision
  • Health Savings Accounts
  • Health Care & Dependent Care Flexible Spending Accounts
  • Disability Benefits
  • Life Insurance
  • Retirement Benefits
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