Inogen, Inc.
  • RA/QA
  • Richardson, TX, USA
  • Part 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 Regulatory Affairs/Quality Management Systems Clerk has responsibility for supporting the initiatives of the Regulatory Affairs department. The position is specifically responsible for executing assigned tasks which support the completion of the department initiatives.

Key Competencies:

  • Assist in supporting product registrations, license renewals, & establishment registration activities
  • Provide support during regulatory agency inspections, external audits & internal audits
  • Assist in the administration of the Corrective & Preventive Action System
  • Create and submit Document Change Requests to implement system revisions and/or technical document revisions into the system
  • Complete Kaizen Project/cross-functional process improvement tasks, as assigned
  • Aid in daily document control administration activities such as change control & record retention
  • Complete various regulatory research projects, as assigned
  • Other duties, as assigned

Do you possess these abilities?

  • General knowledge of Microsoft Office (Word, Excel, PowerPoint,Outlook)
  • General working knowledge of software such as Adobe Acrobat
  • Familiarity with general office hardware such as printers & scanners

Requirements:

  • BS in Engineering, Biological Science, or other technical discipline or equivalent
  • Preference given to candidates with some familarity of Medical Device Regulations (i.e. FDA 21 CFR 800 series, ISO 13485, MDD 93/42/EEC, etc).

Working Conditions:

  • Normal office environment working conditions

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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