Description Job Description
Job Title:Quality Engineer IReports to:TBDDepartment:Quality & Regulatory AffairsExempt:?Date Created:July 17, 2024Location:Plano, TXJob Summary:
As a Quality Engineer at Inogen, you will support our Quality Management System, ensuring compliance with regulatory standards and maintaining the highest level of product quality.
You will collaborate with cross-functional teams on new product development, manufacturing processes, supplier quality, and post-market activities.
Your contributions will be vital in driving continuous improvement and ensuring the safety and efficacy of our products.
Responsibilities (Specific tasks, duties, essential functions of the job): Support new product design and development activities.
Collaborate with the new product development team to ensure quality and regulatory standards are met from conception to launch.
Participate in post-market surveillance activities to monitor product performance and address any quality issues.
Facilitate the effective transition from product design to production.
Assist with manufacturing and quality activities for improvement and risk.
Aid in achievement quality initiatives.
Manage post-market activities, such as complaint investigations, medical device reporting, and data analytics.
Conduct root cause investigations and implementing Corrective and Preventive Action (CAPA).
Develop and implement quality management system procedures.
Participate in internal and external audits.
Oversee supplier qualification and monitoring activities.
Ensure compliance with Inogen's quality management system and applicable medical device regulations in activities associated with the role.
Knowledge, Skills, and Abilities: The ability to work onsite Monday through Friday during normal working hours at the Inogen facility in Plano, TX.
Ability to learn Inogen products, processes, and applicable medical device regulations Ability to multitask, meet deliverables, and work in a team environment Ability to compile data from various sources to produce useful reports.
Excellent oral and written communication skills.
Ability to effectively interface with different departments within the company.
Utilize analytical & problem-solving skills to manage complex project deliverables.
Attention to detail with accurate and complete documentation.
Excellent planning, communication, and organizational skills.
Basic knowledge/proficiency of Microsoft Office Qualifications (Experience and Education): Bachelor's degree in engineering or a related scientific field of study.
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.