Inspire Medical Systems · 12 hours ago
Director, Quality Systems
Minneapolis, MN
Full-time
Onsite
Director/Executive
$170K/yr - $230K/yr
15+ years expInspire Medical Systems is a pioneering company focused on improving the lives of individuals with Obstructive Sleep Apnea through innovative medical devices. The Director of Quality Systems will lead the development and enhancement of the global quality system, ensuring compliance with regulations and driving continuous improvement across the organization.
BiotechnologyHealth CareMedical DeviceTherapeutics
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
Provide quality expertise for non-product software validations (including ERP/MRP tools) and lead quality assurance teams supporting non-product software validations
Lead QMS continuous improvement projects to increase efficiency of the QMS and drive organization compliance
Perform, support, mentor and coach others on effective root cause investigations and CAPA actions to maintain effective and compliant quality systems and products
Ensure QMS competency-based learning is in place for all QMS processes for both Inspire employees and contractors
Recruit, coach, mentor and develop top talent for the quality team
Lead effective change management across the organization
Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed
Complete training requirements and competency confirmations as required for this position within the required timeline
Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement
Ensure all direct reports maintain training records that comply with applicable quality system requirements
Qualification
Required
Minimum of 15 years working in medical device quality systems
Minimum of 10 years managerial experience
Minimum of 5 years in a medical device compliance and/or audit role
Experience working directly with FDA, Notified Bodies or other geographic regulators during regulatory inspections/audits (front room)
In depth knowledge of and implementing global medical device regulations (21 CFR 11, 820, 801, 803, 806, 821, 822, 830, JPAL, EU MDR, MDSAP, ISO 13485, etc.)
Demonstrated leadership and project management skills with the ability to prioritize and execute
Proficient with Microsoft Word, Excel, and PowerPoint
Proficient with other MS applications (i.e.; Power BI, SharePoint, OneDrive, etc.)
Bachelor's degree in science, engineering, technology, or biomedical discipline
Preferred
15 years' experience in a medical device quality management role
5 years managing electronic QMS system/workflow implementations
5 years working with nonproduct software validation requirements
Experience working directly with FDA, Notified Bodies or other geographic regulators on product recalls
Demonstrated QS leadership by: Implementing and obtaining certification (FDA & ISO) of a quality management system
Implementing and validating an electronic QMS software tool to transition existing paper processes into electronic workflows
Demonstrated high level of strategic thinking, customer/patient focused risk assessment and judgement
Demonstrated creative and effective problem solving and out of the box thinking for quality system and compliance solutions
Strong interpersonal and communication (both verbal and written) skills. Ability to facilitate teams and deliver presentations
Effective relationship management, ability to network, support and influence across the entire organization
Proven success in coaching, developing, and managing people
Master's degree in a technical or scientific field
Benefits
Multiple health insurance plan options.
Employer contributions to Health Savings Account.
Dental, Vision, Life and Disability benefits.
401k plan + employer match.
Identity Protection.
Flexible time off.
Tuition Reimbursement.
Employee Assistance program.
All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.
Company
Inspire Medical Systems
Inspire Medical Systems develops implantable therapeutic devices for the treatment of obstructive sleep apnea.
1001-5000 employees
H1B Sponsorship
Inspire Medical Systems has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
2023 (2)
2022 (2)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$319.4MKey Investors
Amzak Capital ManagementOrbiMedMedtronic
2020-04-13Post Ipo Equity· $133.4M
2018-12-18Post Ipo Equity· $75M
2018-05-03IPO
Leadership Team
Tim Herbert
Chairman & CEO
Richard Buchholz
CFO
Recent News
2026-01-07
Company data provided by crunchbase