Inspiresleep
Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA‑approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.
Why Join Our Fast‑Growing Team At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people‑first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement. If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team!
Essential Job Functions This leadership role focuses on overseeing and enhancing Inspire’s global quality system. The position leads teams responsible for configuration assurance, quality systems compliance, QMS training and audit, quality operations, non‑product software design assurance and eQMS development and implementation, ensuring compliance with global regulations and driving continuous improvement. The role collaborates with multiple stakeholders across the organization, including design assurance, post‑market quality, operations, information services, product development and regulatory to achieve organizational goals and foster a high‑performing workplace.
Opportunities You Will Have in This Role
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.
What You Can Bring to Our Great Team 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 judgment.
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
Salary $170,000 – $230,000 USD
Benefits and Other Compensation
Multiple health insurance plan options
Employer contributions to Health Savings Account
Dental, Vision, Life and Disability benefits
401 k plan + employer match
Identity Protection
Flexible time off
Tuition Reimbursement
Employee Assistance program
Participation in equity awards and the Employee Stock Purchase Program
Equal Employment Opportunity Statement Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, pregnancy or childbirth, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non‑discrimination in employment in every location in which it has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.
Inspire Medical Systems participates in E‑Verify.
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Why Join Our Fast‑Growing Team At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people‑first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement. If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team!
Essential Job Functions This leadership role focuses on overseeing and enhancing Inspire’s global quality system. The position leads teams responsible for configuration assurance, quality systems compliance, QMS training and audit, quality operations, non‑product software design assurance and eQMS development and implementation, ensuring compliance with global regulations and driving continuous improvement. The role collaborates with multiple stakeholders across the organization, including design assurance, post‑market quality, operations, information services, product development and regulatory to achieve organizational goals and foster a high‑performing workplace.
Opportunities You Will Have in This Role
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.
What You Can Bring to Our Great Team 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 judgment.
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
Salary $170,000 – $230,000 USD
Benefits and Other Compensation
Multiple health insurance plan options
Employer contributions to Health Savings Account
Dental, Vision, Life and Disability benefits
401 k plan + employer match
Identity Protection
Flexible time off
Tuition Reimbursement
Employee Assistance program
Participation in equity awards and the Employee Stock Purchase Program
Equal Employment Opportunity Statement Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, pregnancy or childbirth, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non‑discrimination in employment in every location in which it has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.
Inspire Medical Systems participates in E‑Verify.
#J-18808-Ljbffr