Quality Engineer; Pharmaceutical

Quality Engineer (Pharmaceutical)

Quality Assurance

Irvine , California, US

• Added - 26/05/2026

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)

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.

• 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.

• 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.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.