Job Details

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

• Bachelor's degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 8 years of experience in quality management within the medical device industry, including at least 5 years of managing a Quality Assurance team.
• Experience at companies with over $1B revenue.
• Strong knowledge of ISO 13485, FDA regulations, and other relevant quality standards.
• Proven track record of leading successful audits and regulatory inspections.
• Excellent leadership and team management skills.
• Strong analytical, problem-solving, and decision-making abilities.
• Effective communication and interpersonal skills.
• Detail-oriented with a strong commitment to quality and compliance.