Sr. Manager, QMS & Compliance

The role

This is a senior leadership role overseeing Inspire's global quality systems, including quality systems compliance, QMS training and audit, and configuration assurance. The role also covers eQMS development, implementation and validation, and works with Operations, Manufacturing, Regulatory Affairs, Training and Executive leaders.

What you will do

• Lead and maintain an effective quality system, including QMS structure, quality planning, and monitoring of all QMS processes and metrics.
• Develop and implement the annual quality plan, quality objectives and quality metrics.
• Lead development and implementation of new electronic QMS process workflows for current and new geographic regulations.
• 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 and compliance.
• Ensure competency-based learning is in place for all QMS processes for employees and contractors.
• Recruit, coach, mentor and develop top talent for the quality team.

Required qualifications

• Bachelor's degree in a technical or scientific field, or a Bachelor's degree in any discipline with at least 8 years of experience in medical devices.
• At least 5 years in a medical device design assurance role, software quality assurance role and/or medical device post market role.
• Extensive knowledge of complaint handling and global vigilance requirements for ISO, FDA and European Medical Device Regulations/QMS requirements and other geographies (e.g. ISO 13485; 21 CFR Part 820

Benefits

• Multiple health insurance plan options.
• Employer contributions to Health Savings Account.
• Dental, Vision, Life and Disability benefits.
• 401k plan with employer match.
• Identity Protection.
• Flexible time off.
• Tuition Reimbursement.
• Employee Assistance program.
• Equity awards and Employee Stock Purchase Program.

Before you apply

• Inspire participates in E-Verify.
• Applicants with a disability who need accommodation to complete the application can contact Human Resources at 844-672-4357 or careers@inspiresleep.com.

About the company

Inspire Medical Systems makes an FDA-approved medical device that reduces obstructive sleep apnea severity for people who cannot tolerate or get consistent benefit from CPAP. The company states it puts patient outcomes first.