Senior Manager, Quality Management System

Description

Job Summary

The Senior Manager, QMS has responsibility for Inogen’s Quality Management System (QMS) including compliance with applicable regulations and standards, system performance, strategic leadership, and oversight of quality initiatives. This role is based in Plano, TX and ensures that all products and processes comply with regulatory standards, company policies, and industry best practices. The Senior Manager will lead the QMS team to achieve quality objectives and continuous improvement.

Responsibilities

• Develop, refine, and maintain the Quality Management System to ensure compliance with ISO 13485, FDA regulations, EU MDR, and other relevant standards and to achieve long-term quality strategies and business initiatives.
• Manage and maintain a team of QMS professionals per the approved budget and annual operating plan. Provide development and guidance to staff on quality management practices and standards.
• Support development of annual department budget and resource planning.
• Lead internal and external audits, including regulatory inspections, and ensure timely and effective resolution of audit findings.
• Collaborate with cross-functional teams to define and support creation or improvements to SOPs and work instructions.
• Monitor and report on QMS metrics within monthly reviews and periodic Management Reviews, identifying areas for improvement and implementing corrective actions.
• Manage the CAPA process, ensuring effective root cause analysis and implementation of corrective and preventive actions.
• Ensure that all product documentation, including Design History Files and Device Master Records, are accurate and complete.
• Support product development teams in risk management activities and ensure that risk management procedures are established and assessments are conducted and documented.
• Stay current with industry trends and advancements, ensuring the QMS evolves to meet changing requirements.

Qualifications

Inogen assesses market data to ensure a competitive compensation package for our employees.  The base salary for this position is expected to be between $109,000.00 and $137,355.00 annually. However, actual base salary if hired will be determined on an individualized basis and will be based on non-discriminatory factors, including as to individual skills, education, experience and market location.

Our Benefits and Rewards :

In addition to the expected base salary, this role is eligible to participate in Inogen’s annual performance bonus incentive plan, highly competitive and company-sponsored benefits, and wellbeing programs rooted in our strong culture of excellence. As a valued member of our team, Inogen provides health, dental, and vision insurance, 401(k) plan plus employer contribution and match, and generous paid leaves such as vacation and sick leave, including paid volunteer time, that can support you and your family through moments that matter.

Inogen is an Equal Employment Opportunity / Affirmative Action Employer - Underrepresented racial and ethnic groups / Females / Individuals with Disabilities / Protected Veterans.