Job Description

Six month assignment Monday thru Friday - ABC
Our client is seeking a more junior engineer for this role. 

You will be responsible for the following:

  • You will create, execute, and document functional test protocols for new and existing software.
  • Maintaining product requirements, trace matrices, test reports, work instructions and other product documentation in compliance with FDA and ISO/CE regulations, and internal development processes and design controls.
  • Prepare release documentation including release notes, risk assessments and other deliverables and drive releases through the Change Order process.
  • Other tasks as needed.

Skills and Experience:

  • Bachelor’s degree in Computer Science, Engineering or relevant Life Science discipline
  • 3-4 years of relevant job experience with functional device testing
  • Experience working in medical device development R&D or QA department
  • Proficient with Microsoft Office.

    Plus:
    • Experience with FDA 21 CFR Part 820, 21 CFR Part 11, and ISO 13485 is a strong plus

      It is the policy of GCR to provide equal opportunity to all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. GCR is an Equal Opportunity/Affirmative Action Employer and embraces diversity in our employee population.
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Application Instructions

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