Pay Rate Low: 100000 | Pay Rate High: 120000
Opportunity to join a rapidly growing pharmaceutical organization in a highly impactful Quality Engineer capacity.
Salary: $100-120k/yr
Hybrid (Irvine OR LA)
Position Overview We are looking for a Quality Engineer to support quality assurance, process optimization, and regulatory compliance within a regulated manufacturing environment. This role works closely with cross-functional teams to identify quality concerns, improve operational processes, and ensure products consistently meet safety and compliance standards.
Primary Responsibilities - 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.
Required 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.
- Hands-on experience with validation processes, risk management, and quality systems.
- Strong understanding 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.
