Sr. Validation Software Engineer I (QMS) in San Diego, CA at Apex Life Sciences

Date Posted: 11/14/2018

Job Snapshot

Job Description


Our Client, a leader in rapid point-of-care diagnostics is seeking a Validation Software Engineer. For immediate consideration, please email resumes to Dave Hurt at dhurt@apexlifesciences.com!

Summary:

  • Develop, review and approve of validation documents such as Operation Qualification Plan, Operation Qualification Reports, Protocol Qualification Reports, Protocol Test Script and Installation Qualification Execution Report.
  • Implement validation activities, common operation qualification test execution, test script and acceptance testing,
  • Report software validation test results in structured way plus suggest on deliverables quality internal
  • Comply with company guidelines and policies utilizing software validation process and work instructions.
  • Demonstrates mastery in software testing and interpretation of End user requirements.
  • Creates Operation qualification test cases and executes tests cases.
  • Facilitate functional risk assessment (if applicable)
  • Assists the Software Validation Group Leader in software test planning as a member of the team.
  • Report about product quality to project management as required.
  • Work with end users and process owners to collect data to support protocol requirements, analyze data collected and create validation reports.
  • Learn and understand the applicable technology and engage in technical discussions.

Requirements and Education:

  • Requires a Bachelors degree in engineering or science and a minimum of 2 years of related experience.
  • Experience in medical device industry in the development and deployment of Quality Systems, process controls, and continuous improvement methods is strongly preferred
  • 5-10 years in quality assurance engineering experience in an FDA regulated environment is strongly preferred.
  • Intermediate knowledge and working application of Validation Principles and guidelines and industry practice
  • Knowledge and working application of standard operating procedures.
  • Demonstrated ability to accomplish goals while working across departments is required.
  • Computer competency in MS Office.
  • Excellent interpersonal, written, and verbal communication skills.
  • Adaptable to fast-paced, dynamic work environment with ability methodically manage projects.

#LI-HURT

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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