Skip navigation
Unable to save this job. Please try again later.


Email this Job to Yourself or a Friend

To begin the application process, please enter your email address.

Company Contact Info

  • Los Angeles, CA

Already have an account?

Sign in to apply with your saved resumes.

New to CareerBuilder?

Don't have an account? Continue as a guest!

Sorry, we cannot save or unsave this job right now.

Report this Job

Trust and Site Security Team.

Don't miss out on new jobs!

Get the latest Principal Quality Engineer jobs in Los Angeles, CA delivered directly to your inbox. You can unsubscribe at any time.

Saving Your Job Alert

Job Alert Saved!

Could not save Job Alert!

You have too many Job Alerts!

This email address has reached the maximum of 5 email alerts. To create a new alert, you will need to log into your email and unsubscribe from at least one.

Sign Up

or   Sign In Here
Password Must Contain
8 to 15 characters
1 uppercase letter
1 number or symbol
1 lowercase letter
Create an Account with CareerBuilder to save jobs & unlock these great features
See similar job titles and skills to help you make your next move
Upload a resume and become visible to Hiring Managers and Employers
Compare Salary Information to see where you stand amongst your peers
Easily Quick Apply to jobs with just one click!

Email Send Failed!

Principal Quality Engineer

Astrix Technology Group • Los Angeles, CA

Posted 6 days ago

Job Snapshot

Travel - None
Experience - 2 years
Degree - 4 Year Degree
Biotechnology, Pharmaceutical
Biotech, Pharmaceutical, Science

Job Competition



How Do You Compare to the Competition?

Get facts about other applicants with a CareerBuilder Account

Job Description

Title: Principal Quality Engineer 

Contract Duration: 12 - 36 months (potential extension or permanent conversion)

Job Summary

This key role in the Quality organization will assist with the co-development, commercialization, and lifecycle management for diagnostic and companion diagnostic devices (IVD’s) to support therapeutics' team. The role will be highly visible, interacting with cross-functional internal European and U.S. management and technical team members, and multiple IVD manufacturers, to prepare for and execute activities including manufacturer due diligence and evaluation, manufacturer auditing, design control, inspection readiness and lifecycle management. The position will report to a member of the Device Quality department leadership team and provide thought leadership and current best practices surrounding considerations and continued development of internal processes related to control of IVDs. 

Job Description

  • Employ quality principles and company’s procedures including but not limited to the areas of Purchasing Controls, Design Controls, Change Controls and NC/CAPA, Risk Management, Human Factor Engineering, Process Validation, and Manufacturing and Distribution, to ensure co-development and sustainment of IVD products complies with applicable regulations and standards. 
    • IVDs intended to diagnose a condition Amgen’s therapeutics treat 
    • IVDs intended for Amgen drug titration 
    • IVDs intended to monitor a condition Amgen’s therapeutics treat 
  • Train and educate key functional partners and management on regional and international IVD requirements, standards and regulations.
  • Suggest and participate in improvements to the quality system, particularly related to IVDs.
  • Provide Quality leadership for regulatory interactions for IVDs.
  • Review and approve procedures and work Instructions. 

Job Requirements

Skills Required:

  • Doctorate degree and 2 years of directly related experience OR 
    Master’s degree and 6 years of directly related experience OR 
    Bachelor’s degree and 8 years of directly related experience 
  • Experience with audits, quality inspections, and quality agreements such as purchasing controls.
  • Quality/Technical experience within GMP regulated IVD manufacturer (IVDD, IVDR, FDA QSR).
  • Ability to teach IVD experience to a high-performing staff with only device quality background.

Preferred Background:

  • 5+ years of Quality, Engineering or Operations experience in the IVD medical device industry. 
  • Experience with quality systems including: 21 CFR 820, European Medical Device Directives (MDD) and Medical Device Regulations (MDR), IEC 62304, ISO 13485, ISO 14971, IEC 62366. 
  • Knowledge of Medical Device Design Controls, particularly for in vitro devices.
  • Experience working in in vitro device development, manufacturing or validation function is a plus. 
  • Experience with designing and executing IVD clinical trials is a plus, particularly as part of a co-development agreement between a biopharmaceutical manufacturer and an IVD manufacturer.
Help us improve CareerBuilder by providing feedback about this job: Report this Job.
For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.
By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.
Don't miss out on new jobs like this
Get the latest jobs delivered to your inbox. Unsubscribe at any time.

Saving Your Job Alert

Job Alert Created

Well, this is embarrassing. We are having trouble saving your search. You can try again or come back at a later time.

Maximum Email Alerts

This email address has reached the maximum of 5 email alerts. To create a new alert, you will need to log into your email and unsubscribe from at least one.