Engineer - 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:
    114470
  • Contact Name
    Volt Branch
  • Phone
    916/923-0460

Job Description

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

The 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 with a minimum 5 years of related 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 about this great opportunity!

Volt is an equal opportunity employer.