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Design Quality Assurance Manager (Remote)

Virtual Req #773
Monday, June 27, 2022
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 Summary:


The Design Quality Assurance Manager (Remote) has the responsibility for all activities related to the Quality Engineering function, providing oversight and direction in the areas of design controls, risk management, validation, data analytics and product improvement. Works in close collaboration with engineering teams and design assurance to ensure product quality is established and maintained at the highest level.

 

Responsibilities (Specific tasks, duties, essential functions of the job)

  • Leading a team of Design Quality Engineers in providing guidance to project teams both as a manager and as a Subject Matter Expert to Core Teams regarding Design Controls, related regulations and the internal processes.
  • Acting as a “Super User” in the interpretation of the Design Controls process outside of specific projects as they apply to business needs.
  • Support engineering development teams throughout the development lifecycle to ensure robustness in the design.
  • Lead your team and work with others in the organization to develop and apply advanced statistical tools to measure and metric develops to support EU-MDR Part 88, other forms of trending analysis for rare events, and product reliability modeling.
  • Perform Post Market Risk Assessment to determine the effect of product defects on field residual risk and assess against the company Safety Policy for acceptability/unacceptability. Must be able to present this to MT level Councils for review and approval.
  • Facilitate Design Failure Modes Effects Analysis (FMEA) for diverse engineering teams involving software and hardware from system level to unit level.
  • Support resourcing CAPA ownership – driving resolution of issues through the CAPA process maintaining schedule and compliance to process and intent.
  • Develop team members of varying experience levels to continue to grow in expertise and capability as individual contributors.
  • Assist with any other duties as assigned.

Knowledge, Skills, and Abilities

  • Ability to establish technical credibility and partner both for your yourself and your team with a high-performance leading-edge technology and product development organization.
  • 10+ years of relevant experience in the field including demonstrated leadership and people management skill set.
  • Strong mastery of Quality principles such as the structure and topic areas of a Quality System, CAPA, Reliability, Root Cause investigation concepts and tools, etc.
  • Ability to teach, mentor and provide expert application of Design Quality concepts and tools such as Verification vs. Validation, Requirements Development and decomposition vs. Specification development, Safety Risk Management and FMEA
  • Experience with data extraction and analysis tools preferred, such as SQL, Minitab, R, etc.
  • Ability to work both independently and as part of a team in a global organization with multiple partner organizations, such as Clinical and Medical Affairs, Research and Development and Manufacturing/Manufacturing Engineering.
  • Comfort in both office and manufacturing line environments.
  • Preferred experience with EU-MDR, 21CFR820, ISO 13485, ISO 14971/TS 24971, IEC 60601, IEC 62366, IEC 62304, IEC 60812/VDA FMEA Handbook.
  • ASQ CQE, CRE, CQM or related certifications are a plus.
  • Experience working in a complex hardware design/development role is a plus.

Qualifications (Experience and Education)

  • Bachelors of Science in a relevant technical discipline - required.
  • Graduate technical degree or specific knowledge in statistical methods - preferred. Experience demonstrating this level of theoretical engineering knowledge as an alternative will be considered.
We thank all applicants in advance for their interest in the position. However, only those selected for an interview will be contacted. 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 legallyprotected 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: https://www.dol.gov/agencies/ofccp/faqs/pay-transparency 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.

Other details

  • Job Function Management
  • Pay Type Salary
  • Employment Indicator Insider
  • Required Education Bachelor’s Degree