Inspiresleep
Overview
Inspire is a medical device company focused on reducing OSA severity for patients who cannot tolerate or benefit consistently from CPAP. This role leads Inspire’s global quality system, guiding quality strategy, compliance, and continuous improvement across the organization. ESSENTIAL JOB FUNCTIONS
This leadership position oversees and enhances Inspire’s global quality system, including configuration assurance, quality systems compliance, QMS training and audits, quality operations, non-product software design assurance, and eQMS development and implementation. The role ensures compliance with global regulations and drives continuous improvement. The position collaborates with design assurance, post-market quality, operations, information services, product development, and regulatory teams to achieve organizational goals and foster a high-performing workplace. OPPORTUNITIES YOU WILL HAVE IN THIS ROLE
Lead and maintain an effective quality system with a strategic QMS structure, quality planning, execution and monitoring of QMS processes and metrics. Develop and implement the annual quality plan, quality objectives and quality metrics that drive business objectives, continuous improvement and regulatory compliance. Lead the development and implementation of electronic QMS process workflows to drive compliance with current and future geographic regulations. 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) and lead QA teams supporting non-product software validations. Lead QMS continuous improvement projects to increase efficiency and regulatory compliance. Perform, support, mentor and coach root cause investigations and CAPA actions to maintain compliant quality systems and products. Ensure QMS competency-based learning for all QMS processes for Inspire employees and contractors. Recruit, coach, mentor and develop quality team talent. Lead effective change management across the organization. Document product and therapy related field reports within prescribed timelines and provide necessary follow-up documentation. Complete training requirements and competency confirmations within required timelines. Comply with quality system procedures/policies and suggest continuous process improvements. Ensure 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 in medical device quality systems Minimum of 10 years managerial experience Minimum of 5 years in medical device compliance and/or audit roles Experience with FDA, Notified Bodies or regulators during inspections/audits (front room) In-depth knowledge of 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, PowerPoint and other MS applications (Power BI, SharePoint, OneDrive, etc.) Bachelor’s degree in science, engineering, technology, or biomedical discipline Preferred:
15 years in medical device quality management roles 5 years managing electronic QMS system/workflow implementations 5 years working with non-product software validation requirements Experience working with FDA/Notified Bodies on product recalls Demonstrated QS leadership by implementing certification (FDA & ISO) of a QMS and transitioning to electronic QMS tools Strategic thinking with patient-focused risk assessment and judgement Creative problem solving for quality system and compliance solutions Strong interpersonal and communication skills; ability to facilitate teams and deliver presentations Relationship management and cross-functional influence Proven coaching, development, and people management Master’s degree in a technical or scientific field Salary and Benefits
The salary for this position is offered based on experience and qualifications. Salary range: $170,000 - $230,000 USD. Inspire offers a highly competitive benefits package including health insurance options, HSA employer contributions, dental, vision, life and disability coverage, 401(k) with employer match, equity opportunities, tuition reimbursement, Employee Assistance program, and flexible time off. EEO STATEMENT
Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, 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 laws. Inspire complies with applicable laws governing non-discrimination in employment in every location where Inspire has facilities. All employment decisions are made without unlawful discrimination. Equity and inclusion: Inspire is an equal opportunity employer; applicants requiring accommodations should contact Human Resources. #LI-Onsite Eligible applicants may be subject to background check and drug screen as part of pre-employment process.
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Inspire is a medical device company focused on reducing OSA severity for patients who cannot tolerate or benefit consistently from CPAP. This role leads Inspire’s global quality system, guiding quality strategy, compliance, and continuous improvement across the organization. ESSENTIAL JOB FUNCTIONS
This leadership position oversees and enhances Inspire’s global quality system, including configuration assurance, quality systems compliance, QMS training and audits, quality operations, non-product software design assurance, and eQMS development and implementation. The role ensures compliance with global regulations and drives continuous improvement. The position collaborates with design assurance, post-market quality, operations, information services, product development, and regulatory teams to achieve organizational goals and foster a high-performing workplace. OPPORTUNITIES YOU WILL HAVE IN THIS ROLE
Lead and maintain an effective quality system with a strategic QMS structure, quality planning, execution and monitoring of QMS processes and metrics. Develop and implement the annual quality plan, quality objectives and quality metrics that drive business objectives, continuous improvement and regulatory compliance. Lead the development and implementation of electronic QMS process workflows to drive compliance with current and future geographic regulations. 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) and lead QA teams supporting non-product software validations. Lead QMS continuous improvement projects to increase efficiency and regulatory compliance. Perform, support, mentor and coach root cause investigations and CAPA actions to maintain compliant quality systems and products. Ensure QMS competency-based learning for all QMS processes for Inspire employees and contractors. Recruit, coach, mentor and develop quality team talent. Lead effective change management across the organization. Document product and therapy related field reports within prescribed timelines and provide necessary follow-up documentation. Complete training requirements and competency confirmations within required timelines. Comply with quality system procedures/policies and suggest continuous process improvements. Ensure 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 in medical device quality systems Minimum of 10 years managerial experience Minimum of 5 years in medical device compliance and/or audit roles Experience with FDA, Notified Bodies or regulators during inspections/audits (front room) In-depth knowledge of 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, PowerPoint and other MS applications (Power BI, SharePoint, OneDrive, etc.) Bachelor’s degree in science, engineering, technology, or biomedical discipline Preferred:
15 years in medical device quality management roles 5 years managing electronic QMS system/workflow implementations 5 years working with non-product software validation requirements Experience working with FDA/Notified Bodies on product recalls Demonstrated QS leadership by implementing certification (FDA & ISO) of a QMS and transitioning to electronic QMS tools Strategic thinking with patient-focused risk assessment and judgement Creative problem solving for quality system and compliance solutions Strong interpersonal and communication skills; ability to facilitate teams and deliver presentations Relationship management and cross-functional influence Proven coaching, development, and people management Master’s degree in a technical or scientific field Salary and Benefits
The salary for this position is offered based on experience and qualifications. Salary range: $170,000 - $230,000 USD. Inspire offers a highly competitive benefits package including health insurance options, HSA employer contributions, dental, vision, life and disability coverage, 401(k) with employer match, equity opportunities, tuition reimbursement, Employee Assistance program, and flexible time off. EEO STATEMENT
Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, 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 laws. Inspire complies with applicable laws governing non-discrimination in employment in every location where Inspire has facilities. All employment decisions are made without unlawful discrimination. Equity and inclusion: Inspire is an equal opportunity employer; applicants requiring accommodations should contact Human Resources. #LI-Onsite Eligible applicants may be subject to background check and drug screen as part of pre-employment process.
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