Sr. Director, Quality Systems & Compliance

Inspire Medical Systems • Minneapolis, MN

15h • $200,000 - $275,000 • Onsite

About The Position

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. This position is a leadership role focused on overseeing and enhancing Inspire’s global quality and complaint handling systems. This position involves leading teams responsible for configuration assurance, quality systems compliance, QMS training and audit, quality operations, complaint handling and eQMS development, implementation, and validation ensuring compliance with global regulations and driving continuous improvement. The position will collaborate with multiple stakeholders across the organization, including quality operations, design assurance, complaint handling, operations, information services, product development and regulatory to achieve organizational goals and foster a high-performing workplace

Requirements

• 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, audit, and/or complaint handling 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 Quality Systems leadership by implementing and validating an electronic QMS software tool to transition existing paper processes into electronic workflows.
• Demonstrated project management skills with the ability to prioritize and execute.
• Proficient with Microsoft Word, Excel, PowerPoint, and SharePoint
• Bachelor’s degree in science, engineering, technology, or biomedical discipline

Nice To Haves

• 15 years’ experience in a medical device quality management role.
• 5 years managing electronic QMS system/workflow implementations
• 5 years working in post market surveillance or complaint handling
• 5 years working with nonproduct software validation requirements
• Experience working directly with FDA, Notified Bodies or other geographic regulators on product recalls.
• Demonstrated Quality Systems leadership by implementing and obtaining certification (FDA & ISO) of a quality management system.
• 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.
• Master’s degree in a technical or scientific field

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 and lead quality team members supporting non-product software validations (eQMS, ERP/MRP, and other electronic quality record tools).
• Oversee complaint handling process and management team
• 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.
• Apply and coach the application of quality principles, theories, concepts and tools to complex systems and processes.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager