Quality Systems Manager

Supervisor’s Title: Quality Director

Exempt or Non-Exempt: Exempt

Basic Function

The Quality Systems Manager is responsible for establishing, maintaining, and continuously improving Imricor’s Quality Management System to ensure compliance with all applicable regulatory requirements and standards for medical devices. This role provides leadership across a cross-functional team to ensure quality, regulatory compliance, and inspection readiness throughout the product lifecycle.

Responsibilities

• Quality Management System Leadership

  • 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

• Documentation and Change Management

  • 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

• Audits:

  • 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

• CAPA Management

  • Oversees the Corrective and Preventive Action (CAPA) system, ensuring timely, effective investigations and actions
  • Analyzes quality data and trends to proactively drive system improvements

• Complaint Handling

  • 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

• Post-Market Surveillance

  • 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)