Position Title: Associate Process/Quality Engineer
Location: Irvine, CA
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
- 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