Quality Engineer (Pharmaceutical)

About the role

Opportunity to join a rapidly growing pharmaceutical organization in a highly impactful Quality Engineer capacity. Position is hybrid (Irvine or LA). Salary range: $100,000–$120,000 per year.

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.

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.

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.

Pay

Salary: $100,000–$120,000 per year.