Inogen is looking for a Quality Engineer III to uphold their commitment to excellence by supporting their quality management system, driving new product development, enhancing manufacturing processes, ensuring supplier quality, and overseeing post-market activities from both a quality and regulatory perspective. The role aims to drive continuous improvement and ensure the safety and efficacy of Inogen's medical technology solutions.
Requirements
- Intermediate knowledge of applicable medical device regulations such as FDA QSR, EU MDR.
- Demonstrated ability to understand applicable medical device regulations, and implement them in a compliant way which meets business needs.
- Proficient with Minitab or other statistical analysis software.
- Experience in supporting Design QE activities such as Risk Management, FMEA Verification, and Validation.
- Demonstrated competency supporting manufacturing related activities such as process validation, protocol and report authoring.
- Demonstrated competency in developing and implementing QMS procedures which comply with regulations and meet business needs.
- Demonstrated competency in complaint investigation and data analytics.
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.
Other
- The ability to work onsite Monday through Friday during normal business hours at the Inogen facility in Plano, TX.
- Occasional domestic and international travel may be required (~10%).
- Bachelor’s degree in engineering or related scientific field or study.
- Minimum of three years of experience as a Quality Engineer in the medical device industry.
- Ability to multitask, meet deliverables, and work in a team environment.
