Engineer III - Quality Design Assurance in Fremont, CA at Volt

Date Posted: 5/10/2018

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    Fremont, CA
  • Duration:
    32 weeks
  • Date Posted:
    5/10/2018
  • Job ID:
    114462
  • Contact Name
    Volt Branch
  • Phone
    916/923-0460

Job Description

Volt is seeking an Engineer for Quality Design Assurance for an opportunity in Fremont, CA.  

In this role the Quality Design Assurance Engineer will serve as a core team member on New Product Development projects to ensure compliance with Design Controls per ISO 13485 and FDA QSR.

Requirements:

  • Bachelor's degree and experience in Medical Device / Biologics/ IVD manufacturing or an advanced degree and 2-3 years of direct related experience.
  • Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR, IVDD, Design Control requirements, and ISO 13485.
  • Hands on experience with equipment/process validations is ideal
  • Experience with sample size determination using statistical technique and process control is preferred but not required

Please apply now to learn more.

Volt is an equal opportunity employer.