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Lead Quality Engineer

About the Department

Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes to lead longer, healthier lives.  To support this, Novo Nordisk is conducting research on stem cell therapy.  Stem cell research raises hopes for improved treatment of Type 1 Diabetes and for future treatments with cell transplantation therapy.  This treatment could be offered to people with many different serious chronic diseases caused by the degeneration of specific cells, such as Type 1 Diabetes (T1D). T1D is manifested by the selective destruction of the insulin-producing cells in the body, which leads to a life-long dependence on insulin injections to control blood sugar levels.  Cell therapy may offer a better treatment by replacing the lost cells with new insulin-producing cells derived from stem cells, thus avoiding daily multiple insulin injections as well as numerous blood glucose tests.  This treatment may also offer better blood glucose control, which is crucial to avoid late-stage complications such as blindness and kidney failure.  This team will work to generate new stem cell lines to be used in future cell therapies to treat Type 1 Diabetes, Parkinson's disease, and chronic heart failure.  We recognize the importance of an enjoyable workplace, which stimulates a strong culture of ingenuity and innovation and our support of a healthy work-life balance adds to a best-in-class employee experience. 

 

 

The Position

The purpose of the Lead Quality Engineer role is to ensure medical devices and combination products are compliant with design control regulations and ensure the documentation to support the design history file is supportive of combination product filings.

 

 

Relationships

The Lead Quality Engineer will work at the CMC Stem Cell Manufacture facility located in Fremont, California. The role will report to a member of the Stem Cell Manufacture Leadership Team. Internal stakeholders include employees in Process Development, Manufacturing, Quality Assurance, Quality Control and Analytical Development at Novo Nordisk (NN) Fremont, employees at the Novo Nordisk Research Center Seattle, Inc. (NNRCSI) and Novo Nordisk Corporate office in Denmark. The Lead Quality Engineer will not have any direct reports but will drive projects.

 

 

Essential Functions

  • The Lead Quality Engineer is responsible for providing quality and engineering support for product development in support of product realization activities (i.e., verification & validation testing, inspection activities, acceptance activities, receiving inspection, etc.)
  • Prepare product documentation in support of the design history file, including requirements documentation, design and development plans, verification protocols, CAD drawings, etc.
  • Analyzes data collected as part of design verification and validation studies and process validation studies
  • Prepare reports by collecting, analyzing, and summarizing data, and making recommendations
  • Identify and recommend monitoring and measuring equipment needed to support product realization
  • Establishes statistical confidence levels and reliability intervals by identifying sample sizes
  • Perform independent review of milestone endorsement documentation
  • Establish elements of the QMS to incorporate device requirements as needed
  • Able to explain facts, practices, policies, etc. to others within or outside of the organization. Occasionally need to convince others with mutual interests to accept new concepts, practices, and approache
  • Work cross-functionally within the organization and with partner organizations to align device and combination project objectives

 

Physical Requirements

Ability to work flexible hours as necessitated by the process. Expected travel to be <20%.

 

 

Qualifications

  • Bachelor’s degree required. Degree in biomedical sciences, electrical engineering, mechanical engineering, industrial engineering, biology, chemistry, quality, or a related discipline preferred
  • 8+ years relevant experience required with bachelor’s degree or 5+ years relevant experience with advanced degree
  • Part of the 8+ years of relevant experience includes:
    • Experience with ISO 13485; EN ISO 14971; 21 CFR, Part 820; and (EU) 2017/745 (MDR)
  • Experience with the development of medical devices
  • Experience with quality systems for medical devices
  • Experience with the development of combination products and cell-based products is preferred
  • Experience with catheters, dose pumps, and implantable devices is preferred

 

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

 

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Lead Quality Engineer

Fremont, CA
Full Time

Published on 05/17/2020