Quality Engineer III (QMS) in San Diego, CA at Apex Life Sciences

Date Posted: 11/2/2018

Job Snapshot

Job Description


This position is in direct support of site integration and quality system remediation.  The Quality Engineer III (QMS) shall be responsible for collaboration with Validation Engineers on Validation Protocol creation, review, execution, and final review of executed deliverables.  Experience as a QA reviewer and signatory of validations is essential to the job role.

The ideal candidate will have demonstrated ability and experience in providing Quality input into validations, including strategy, verbiage, and review.

Experience/Education:

  • BS degree or equivalent.  An engineering or science background is preferred. Master’s degree preferred.
  • Minimum of five to seven years related experience in quality or engineering (medical device / diagnostics strongly preferred).   Minimum of three years’ experience with a Master’s degree
  • Experience with root cause analysis, failure mode analysis, verification, equipment qualification, and validation
  • Statistical tools including basic statistical inference, graphical methods, regression
  • ASQ (ie – CQE, CMQ/OE, etc…) and/or six sigma certification preferred
  • Core Competencies:
    • Analytical/Problem Solving Skills (e.g. statistical, risk analysis, engineering analysis)
    • Writing and Communication Skills (e.g. write technical reports, present data analysis)
    • Interpersonal Skills
    • Service Orientation
    • Working knowledge of FDA regulations

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.




910912