Quality Engineer III- Scientist in Fremont, CA at Volt

Date Posted: 6/23/2018

Job Snapshot

  • Employee Type:
  • Location:
    Fremont, CA
  • Duration:
    24 weeks
  • Date Posted:
  • Job ID:
  • Contact Name
    Volt Branch
  • Phone

Job Description

Volt is looking for a Quality Engineer III for our client in Fremont, CA. The Quality Engineer will act as the liaison between Quality and Business Development OEM support, in alignment with our quality systems as it relates to changes from OEMs or affecting OEMs. The incumbent will interact with various levels internally and externally, if needed, to plan and execute changes to process or product and communicate with OEMs through business development. 

Key Responsibilities: 

  • Quality Representative between Thermo Fisher and business development to support OEMs.
  • Investigate, analyze, and propose improvements and manage processes in the Quality Management System
  • Process changes through electronic document management systems including OEM changes.
  • Manage reviews and approvals needed to maintain product availability during implementation of a change.
  • Present data at business reviews, team meetings, management reviews.

  Minimum Requirements/Qualifications:

  • Position requires a 4-year degree in a technical/science area; an advanced degree is preferred, with three or more years in the medical device industry.
  • Solid technical understanding of InVitro Diagnostic Assays, including Drugs of Abuse, Immunosuppressant and Therapeutic Drug monitoring Assays
  • Understanding of GMP/QSR, ISO13485/CMDR/CE, ANVISA, JPAL and associated regulatory agencies.
  • Excellent communication skills with ability to communicate at all levels within the organization.
  • Ability to operate in a high paced environment
  • Able to influence, negotiate and resolve potential sticking points with diplomacy
  • Ability to lead small scale projects
  • Ability to work independently or in a group setting with little direction
  • Understanding of Design Control and Validation

Volt is an equal opportunity employer