Job Summary

The Senior Director of Quality Management System and Post Market Surveillance is responsible for overseeing management review and quality monitoring, conducting internal and external audits, managing supplier relationships, and maintaining document control. Additional responsibilities include handling complaints, performing Health Hazard Evaluations, Corrections and Removals, utilizing Data Analytics, managing CAPA processes, and ensuring compliance with regulatory standards. The ideal candidate will live in the Boston area or Dallas/Fort Worth area because this role is hybrid. Working on-site in the Beverly or Plano office will be required.

• Lead global Quality Management System and Post-Market Surveillance activities and resources, ensuring alignment with business needs and compliance with applicable medical device regulations.
• Lead Supplier Quality, Internal and External audit related activities and resources globally.
• Establish, monitor, and achieve KPIs, taking prompt action when necessary.
• Develop related budget and maintain costs within budget constraints.
• Attract and maintain talent needed to support the achievement of business objectives.
• Build and maintain strong relationships with internal and external stakeholders.
• Interact with external regulatory agencies leading to successful outcomes.
• Support the development, implementation, and realization of the global Quality Strategy in support of business objectives.

• Demonstrated expertise in development, implementation, and measurement of Quality Management Systems compliant to applicable global medical device regulations.
• Proven track record of successfully achieving and maintaining compliance to applicable global medical device regulations and achieving business objectives.
• Demonstrated competency in development and implementation of global Quality strategy and effective cost management.
• Must have excellent communication, presentation and influencing skills.

• Bachelor of Science degree in business, engineering, quality management or closely related fields.
• At least ten years of quality experience with multinational or medical device companies.
• At least seven years of people management experience in a quality role with multinational or medical device companies.
• At least three years of experience managing people managers in a quality role within multinational medical device companies.

• Participate in meetings spanning multiple global time zones and a minimum of 25% travel.
• Must be able to work in a hybrid role (minimum of 3-days onsite) at Inogen facility located in Plano, TX or Beverly, MA.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.