Quality engineer Jobs in Richardson, TX

Job Summary

As a Quality Engineer at Inogen, you will be instrumental in upholding Inogen's commitment to excellence. You will support our quality management system, drive new product development, enhance manufacturing processes, ensure supplier quality, and oversee post-market activities from both a quality and regulatory perspective. Your expertise will be vital in driving continuous improvement and ensuring the safety and efficacy of our innovative medical technology solutions.

Responsibilities

• Drive new product design and development activities.
• Lead in the effective transition from product design to production.
• Lead and oversee manufacturing and quality activities for improvement and risk.
• Lead in achievement quality initiatives.
• Lead in post-market activities, such as complaint investigations, medical device reporting, data analytics.
• Lead in root cause investigations, corrective and preventive actions.
• Develop and implement quality management system procedures.
• Participates in front room and back room of internal and external audits.
• Lead in supplier qualification and monitoring activities.
• Ensuring compliance to Inogen quality management system and applicable medical device regulations in activities associated with the role.
• Occasional domestic and international travel may be required (~10%).
• Assist in onboarding of new starters and support of other Quality Engineers.
• Develop and deliver training of applicable QMS elements and QE tools, etc.

Knowledge, Skills, and Abilities

Qualifications

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.