- Minneapolis, Minnesota, United States
- On-site
- Full-time · Manager
- $140K–$180K per year
- 8+ years
This position is a leadership role focused on overseeing and enhancing Inspire’s global quality systems. This position involves leading teams responsible for quality systems compliance, QMS training and audit, and configuration assurance. This role also includes eQMS development, implementation, and validation ensuring compliance with global regulations and driving continuous improvement.
Compensation
$140,000—$180,000 USD
Responsibilities
- Lead and maintain an effective quality system which includes a strategic QMS structure, quality planning activities, execution and monitoring of all QMS processes and metrics.
- Develop and implement the annual quality plan, quality objectives and quality metrics that drive business objectives, continuous improvement and compliance to global regulations.
- Lead the development and implementation of new electronic QMS process workflows to drive compliance with current regulations as well as new geographic regulations where products are, or planned to be, distributed.
- Manage teams interacting with external agencies (FDA, Notified Bodies, and Competent Authorities) for inspections and compliance audits.
- Lead QMS continuous improvement projects to increase efficiency of the QMS and drive organization compliance.
Requirements
- Bachelor’s degree in a technical or scientific field
- Bachelor's degree in any discipline with a minimum of 8 years experience in medical devices