Demo
Salary Resume Critique Job Openings

Design Assurance Quality Engineer

Redbock - an NES Fircroft company
Santa Rosa, CA Full Time
POSTED ON 4/14/2025
AVAILABLE BEFORE 5/13/2025

SUMMARY :

Quality Engineer needed to support product development efforts for a medical device innovator.

DUTIES & RESPONSIBILITIES :

  • Design, document and record reviews
  • Component and product QA / Design Assurance
  • Produce relevant and compliant documentation, as it pertains to ISO 13485 and 21 CFR 820
  • Other duties, as required

QUALIFICATIONS & REQUIREMENTS :

  • 3 years of medical device quality experience in new product development and product life cycle management
  • Solid understanding of ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) as well as 21 CFR 820 and ISO 13485
  • Hands-on experience with quality inspections of components, subassemblies, and / or finished products.
  • Experience reviewing design documentation (drawings, specifications, DHFs, test data sheets, etc.)

    • Preferred Qualifications (in addition to what is listed above)

  • Working knowledge of risk management files such as FMEAs and hazard analysis. Solid understanding of ISO 14971 : 2019
  • Prior experience owning NCRs and / or CAPAs

    • LOCATION :

    If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
    Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

    What is the career path for a Design Assurance Quality Engineer?

    Sign up to receive alerts about other jobs on the Design Assurance Quality Engineer career path by checking the boxes next to the positions that interest you.
    Income Estimation: 
    $159,276 - $189,136
    Income Estimation: 
    $106,451 - $133,778
    Income Estimation: 
    $83,806 - $99,902
    Income Estimation: 
    $101,442 - $121,314
    Income Estimation: 
    $101,442 - $121,314
    Income Estimation: 
    $122,860 - $148,594
    Income Estimation: 
    $122,860 - $148,594
    Income Estimation: 
    $159,276 - $189,136
    Income Estimation: 
    $68,970 - $84,869
    Income Estimation: 
    $83,806 - $99,902
    Employees: Get a Salary Increase
    View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

    Job openings at Redbock - an NES Fircroft company

    Sr. Manufacturing Engineer
    Redbock - an NES Fircroft company
    Hired Organization Address Boulder, CO Contractor
    Sr. Manufacturing Engineer (Through mid-August 2025 // Boulder, CO): Join a leading medical device manufacturer as a Sr....
    Senior Manufacturing Engineer
    Redbock - an NES Fircroft company
    Hired Organization Address Boulder, CO Contractor
    Sr. Manufacturing Engineer (Through mid-August 2025 // Boulder, CO): Top 3 Skills Required: Process Validation PLM Exper...
    Global Regulatory Intelligence & Policy (GRIP) Associate
    Redbock - an NES Fircroft company
    Hired Organization Address Bernards, NJ Full Time
    Must be W2 Location 100% remote Length 12 months Duties / Responsibilities : Under direction of GRIP leadership, provide...
    CMC QA Consultant
    Redbock - an NES Fircroft company
    Hired Organization Address Bedford, MA Contractor
    Location : Onsite in Bedford, MA Length: 8 months (through end of 2025) Summary: The CMC QA Consultant will report to th...
    View More Jobs at Redbock - an NES Fircroft company

    Not the job you're looking for? Here are some other Design Assurance Quality Engineer jobs in the Santa Rosa, CA area that may be a better fit.

    NDC Quality Assurance Engineer

    N Consulting Ltd, nice, CA

    Sr. Quality Assurance Engineer

    Endologix, Santa Rosa, CA

    View More Jobs

    AI Assistant is available now!

    Feel free to start your new journey!