Position Title: Associate Process/Quality Engineer

Location: Irvine, CA

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Summary/Contribution of Position:

Engineer experienced in validation of manufacturing equipment, packaging, and processes. Candidate should be familiar with the IQ/OQ/PQ validation process, and the necessary guidelines for ISO 13485 and cGMP.

In this role, you will:
  • Ensure activities are in compliance with company procedures as well as ISO13485 and FDA 21 CFR 820 quality systems
  • Prepare documentation and SOP for validation
  • Perform validations of equipment and processes used in manufacturing
  • Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
  • Support product transfers to other plants/facilities.
  • Participate in the company quality system continuous improvement.
  • Analyze and interpret results
  • Maintain consistent records
Preferred Experience:
  • BS in engineering or related field with at least 2 years industry experience
  • Experience in ISO 13485 or ISO 9001 implementation process
  • Experience in process validation strongly preferred
  • Excellent communication skills, both verbal and written
  • Attention to details and accuracy
  • Knowledge of Microsoft office products
  • Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products
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