Hiring: Quality Engineer (Pharmaceutical) Company: Astrix Location: Irvine, CA Job Posted Time: 2026-09-16 19:28:24 Employment Type: Hybrid Target Skills & Keywords : Regulatory Compliance About the job Experience: •3 years of experience in quality assurance within regulated industries such as pharmaceuticals, medical devices, food, cosmetics, or dietary supplements. Required Skills: •Lead investigations into manufacturing deviations and quality issues, including root cause analysis and corrective/preventive actions (CAPA). •Monitor and improve quality performance metrics to support continuous improvement initiatives. •Create, revise, and maintain SOPs to enhance efficiency and regulatory compliance. •Perform risk assessments (FMEA) and assist with implementation of quality-related projects. •Manage product specifications, supplier qualification activities, and third-party audits. •Coordinate external product certifications such as Halal, Kosher, and NSF. •Support recall readiness, mock recalls, and post-market quality monitoring activities. •Review new products and formulations to ensure compliance with quality and regulatory standards. Qualifications: •Bachelor’s degree in Biology, Chemical Engineering, or a related scientific discipline. •Minimum of 3 years of experience in quality assurance within regulated industries such as pharmaceuticals, medical devices, food, cosmetics, or dietary supplements. •Applied hands-on capability in validation processes, risk management, and quality systems. •In-depth knowledge of cGMP regulations, FDA requirements (21 CFR 111, 117, 210, 211), and ISO 22716 standards. •Knowledge of Six Sigma principles and statistical analysis tools. •Willingness to travel domestically and internationally when required. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!