Complaint Coordinator in Fridley, Minnesota at MicroTransponder

About Mobia Medical

Mobia Medical is a commercial-stage medtech company delivering breakthrough stroke recovery solutions. The company’s Vivistim® Paired VNS™ Therapy is the first and only FDA-approved implantable solution designed to improve function in chronic ischemic stroke survivors with moderate to severe upper limb impairments. Vivistim® Paired VNS™ Therapy combines targeted vagus nerve stimulation with functional movement to promote neuroplasticity and improve the brain’s ability to relearn motor skills. Mobia Medical is mobilizing patients, providers, and care partners to establish a better way forward in stroke care.

About the role

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.

What you'll do

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)

Qualifications

What you bring:

• 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

Preferred qualifications:

• 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

You’ll thrive in this role if you are:

• 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

Equal Opportunity Employer

Mobia Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Mobia Medical provides a comprehensive benefits program to employees. It includes medical, dental and vision plans along with an FSA. Employees may participate in the company 401(k) plan with company matching. The company offers an unlimited Paid Time Off (PTO) program and approximately 18 paid company holidays per year.

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