Job Description

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

• The ability to work onsite Monday through Friday during normal business 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.
• 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.
• Recognized as internal subject matter expert within Mfg QE, Design QE, or QMS/PMS.
• Assist in onboarding of new starters and support of other Quality Engineers.

Qualifications

• 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.

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.

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