Inogen, Inc.
  • RA/QA
  • Richardson, TX, USA
  • Full Time

ABOUT INOGEN Inogen was founded in 2001 to improve quality of life and increase freedom and independence for oxygen therapy users. Inogen is innovation in oxygen therapy. The Inogen mission is to improve freedom and independence for oxygen therapy patients through innovative products and services. Inogen is a manufacturer and Accredited Homecare Provider.

Inogen is focused on quality care, continuous improvement, and outstanding customer satisfaction. We are a stable, USA based company dedicated to providing an exciting and rewarding career to our employees. We completed a successful Initial Public Offering on the NASDAQ in 2014 and have demonstrated substantial growth over the last five years. Our work environment is casual yet high performing, and we are looking for seriously talented, motivated, and fast-paced professionals to join our team.

JOB DESCRIPTION 

The Quality Engineer is responsible for supporting Inogen product development, manufacturing, supplier quality and after-market activities from a quality and regulatory perspective.

Key Competencies:

  • Under the guidance of Quailty Manager, participate in new product design and development process. Measure risk analysis as required. Establish protocols and prepare reports for design validation. Maintain Design History File.
  • Drive effective transition from product design to production. Review manufacturing and quality processes for improvement and risk. Establish Device Master Record.
  • Perform after-market monitoring activities, such as analysis of servicing data, customer complaint processing and medical event reporting.
  • Perform internal and external audits for domestic and international suppliers which may include new supplier approval.
  • Ensure implementation of appropriate corrective action and preventative action (CAPA) for internal and external findings.
  • Work with suppliers on quality improvement projects through use of corrective actions.
  • Ocassional domestic and international travel required (~25%).
  • Introduction and monitoring of lean manufacturing initiatives (5S, line optimization, FMEA, etc)

Do you possess these abilities?

  • Experience with vendor assessment, qualification and process validation. (required)
  • Have a solid foundation of database systems including Oracle and Excel. (required)
  • Demonstrated ability to compile data from various sources to produce useful reports. (required)
  • Demonstrated ability to trend and verify process improvements. (required)
  • Geometric dimensioning & tolerance (GD&T) training preferred.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • While performing the duties of this job, the employee will be sitting at a desk working on a computer. The employee will also be required to use the telephone, speaking with and listening to others.  
  • This job requires them to frequently walk, sit, talk and hear, use hands to finger, handle, or feel objects, tools, or controls. They are regularly expected to reach with hands and arms.
  • The employee must occasionally lift and/or move up to 50 pounds.
  • Specific vision abilities required by this job include close vision and the ability to adjust focus.

 

Working Conditions:

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • The noise level in the work environment is usually moderate.
  • Up to 50% of their time will be spent working on the computer; reading, typing, and training/meeting with others.
  • Up to 50% of their time will be spent in a warehouse environment working with packages, parts, machines, and staff.
  • Some personal protective equipment such as safety glasses, hearing protection, and electrostatic discharge (ESD), may be required.

Requirements:

  • BS degree in Engineering or related science.
  • 1-3 years' experience in Production, Engineering or Quality Assurance.
  • Experience working in a regulated manufacturing environment preferred (i.e., ISO, FDA, FAA).
  • 1 year of auditing experience required.
  • Lean Sigma Black Belt certification, required.

 

WHY INOGEN Inogen is a dynamic company that is not only focused on quality care of patients, but is also committed to being a top employer.  Each of Inogen' s offices have a casual culture that supports employees being responsible and developing professionals.

We offer competitive salaries and a robust benefit package:

  • Employee Stock Purchase Plan 401 (K) plan available for all employees Health, dental, vision insurance Flexible spending accounts and wellness discount program Life Insurance Long Term Disability Robust paid time off and 8 paid holidays Employee Assistance Program

See the Inogen Team in action:

https://www.youtube.com/watch?v=dKoTMeJf5J4

 

Inogen Where we go to work hard to positively impact people's lives

 

Inogen is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. The EEO is the Law poster and its supplement are available here: http://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm; http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf.  The pay transparency policy is available here: http://www.dol.gov/ofccp/pdf/EO13665_PrescribedNondiscriminationPostingLanguage_JRFQA508c.pdf.

Inogen is committed to working with and providing reasonable accommodations to individuals with disabilities.  If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to recruiting@inogen.net or call (972) 616-5668 and let us know the nature of your request and your contact information.

 

 

Inogen, Inc.
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