Complaint Coordinator

Mobia Medical•Fridley, MN

About The Position

At Mobia Medical, we are committed to delivering high-quality, innovative solutions that improve patient outcomes. The Complaint Coordinator plays a vital role within the Quality Assurance team, supporting the safety, performance, and regulatory compliance of our products, including the Vivistim® VNS System. In this role, you will serve as a key contributor to the complaint handling process, ensuring customer feedback and product concerns are properly documented, investigated, and resolved. You will partner with cross-functional teams across Quality, Engineering, Clinical, and Operations to support post-market surveillance activities and maintain compliance with global regulatory standards.

Requirements

Bachelor’s degree in a relevant field and 3+ years of experience, or 7+ years of relevant experience in quality systems or a related function in a regulated industry
Minimum of 3 years of experience in a quality-related role
Working knowledge of medical device regulations and standards (cGMP, FDA 21 CFR Parts 803, 806, 820/QMSR, ISO 13485)
Experience with complaint handling, investigations, and quality systems processes
Strong analytical, problem-solving, and organizational skills

Nice To Haves

Experience, training, or certification in quality engineering
Experience with electronic Quality Management Systems (eQMS), such as Grand Avenue Software
Experience in the medical device industry
Detail-oriented with a strong commitment to quality and compliance
A strong communicator who can collaborate effectively across teams
Able to manage multiple priorities in a deadline-driven environment
Proactive in identifying issues and driving continuous improvement
Comfortable working independently while contributing to team success

Responsibilities

Manage complaint handling and investigations
Coordinate the intake, assessment, investigation, and resolution of product complaints
Review and disposition field experience reports related to product use
Ensure complaint investigations identify appropriate root causes and are completed in a timely manner
Escalate issues as needed for Health Hazard Evaluation (HHE) and/or Corrective and Preventive Action (CAPA)
Support regulatory compliance and reporting
Collaborate with internal teams and field personnel to gather information for adverse event reporting
Support or contribute to Medical Device Reports (MDRs) and other post-market reporting activities
Ensure complaint handling processes align with regulatory requirements and quality standards
Drive post-market data insights and quality improvements
Support post-market data collection, trending, and performance monitoring
Prepare data and documentation for risk reviews, surveillance reporting, and product development inputs
Identify opportunities for process improvement and recommend enhancements
Collaborate cross-functionally
Partner with supplier quality, engineering, and clinical teams to ensure effective issue resolution
Support internal audits and regulatory inspections by providing documentation and records
Maintain accurate records within electronic Quality Management Systems (eQMS)