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Engineer Change Analyst

Fremont, CA

Posted: 08/16/2023 Position Categories: Engineering Pay Rate: 25-30

Job Description

A leading medical device company is seeking a ECO Document Specialist to assist with product release activities, process controls and facility compliance.


  • Customer Acceptance (CA) testing and Commissioning of finished medical devices and analytical instruments manufactured and repaired onsite.
  • Generating and organizing Device History Records (DHRs), along with other testing/product release paperwork.
  • Incoming inspection, acceptance/rejection of parts and components used for production.
  • Communicating with vendors to obtain compliance files as necessary.
  • Coordinate/manage calibrations and preventative maintenance of controlled equipment.
  • Undertake regular facility control checks to ensure Good Manufacturing Practice (GMP).
  • Perform basic data reporting/analysis and trending on product and process performance.
  • Participate in audits and inspections with the Notified Bodies and Regulatory authorities for ISO and QSR compliance, acting as the sites SME for QA/QC.
  • Input into ITL's Quality Management System (QMS) and site specific Standard Operating Procedures (SOPs).
  • Implementation of ITL's QMS SOPs for Design and Development into the Virginia Site.

Job Requirements

Qualifications/Preferred Experience:

  • Must possess at a minimum, a Bachelor's Degree in an Engineering, Manufacturing or Repair Technologies field of study, or similar technical discipline, as well as 3 to 5 years industry experience working in a QA/QC role within a manufacturing type environment.
  • Experience working and implementing compliant SOPs to ISO 13485ISO 9001 and 21 CFR Part 820 is a must.
  • A capacity to work with basic engineering drawings, manufacturing and test procedures, along with inspection, measuring and test equipment, is required.
  • Direct experience working with Medical Devices or electromechanical instrumentation is required.
  • The Ability to work independently, with a strong commitment to customer satisfaction.
  • Experience with Medical Device Risk Management (ISO 14971) is a plus.

Additional Information

For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.


Richmar is an Equal Opportunity Employer.

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