Global Post-Market Surveillance Lead

Inspire Medical Systems, Inc.; Minneapolis (MN); Hybrid; USD 106,000 - 145,000; Full time

Benefits offered by this job

401k matching

ESPP

Flexible time off

Tuition reimbursement

Job summary

Inspire Medical Systems, Inc. seeks a senior Quality/Complaint Handling Leader to oversee global complaint handling quality system requirements and regulations for finished medical devices.

The role manages initiation, investigation, call center staffing and training, with cross-functional collaboration for timely processing. You will build a high-performing team, drive metrics-driven reporting, and mentor staff on ISO 13485 and FDA QMS requirements while upholding patient safety and regulatory

Qualifications

• Bachelor’s degree in a technical or scientific field is required.
• Minimum 5–10 years’ experience in the medical device industry with leadership in customer-facing roles.
• Experience with ISO, FDA and European Medical Device Regulations/QMS.
• Strong communication and ability to manage cross-functional teams.

Responsibilities

• Manage the incoming complaint/product report process and preliminary investigations.
• Lead a team of post-market call center representatives and investigators.
• Staff shifts to ensure coverage and coach on best practices.
• Provide performance reporting on quality processes and metrics.

Skills

Complaint handling

Leadership

Regulatory knowledge

Quality systems

Project management

Education

Bachelor’s degree in technical or scientific field

Bachelor’s degree with 8+ years in implantable medical devices

Tools

MS Word

Excel

Outlook

PowerPoint

Job description

Inspire Medical Systems, Inc. seeks a senior Quality/Complaint Handling Leader to oversee global complaint handling quality system requirements and regulations for finished medical devices.

The role manages initiation, investigation, call center staffing and training, with cross-functional collaboration for timely processing. You will build a high-performing team, drive metrics-driven reporting, and mentor staff on ISO 13485 and FDA QMS requirements while upholding patient safety and regulatory