Quality Systems Manager

Imricor Medical Systems Inc•Burnsville, MN

4d•$130,000 - $165,000•Onsite

About The Position

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.

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

Responsibilities

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.