Quality Compliance Engineer

Pay Rate Low:

90000 |

Pay Rate High:

120000 Our client is a global, publicly traded bioscience leader dedicated to advancing human health-span and healthy aging through strategic, world-class research collaborations.

Title:

Quality Compliance Engineer Location:

Hybrid -

Tustin, CA Schedule:

M-F, 8-5pm. This is a hybrid position. 3 days onsite is a must.

Salary:

$90K-$120K + flexibility for strong candidates Direct Hire We are seeking a Quality Engineer to support quality operations, process improvements, and regulatory compliance in a fast-paced environment. This role will partner cross-functionally to ensure products meet the highest standards for safety, quality, and compliance. Key Responsibilities Lead investigations into manufacturing deviations, nonconformances, and process defects, including root cause analysis and CAPA implementation Drive continuous improvement initiatives using quality metrics, data analysis, and operational KPIs Support SOP development and process optimization initiatives Conduct risk assessments (FMEA), supplier qualifications, and co-manufacturer audits Manage product specifications, third-party certifications (NSF, Halal, Kosher), and recall/mock recall activities Perform quality assessments for new formulas/products to ensure regulatory compliance Collaborate closely with internal teams, external partners, and suppliers Qualifications BS degree in Biology, Chemical Engineering, or related scientific field 3+ years of Quality Engineering/QA experience within pharmaceuticals, CDMO, medical device, food, cosmetics, or dietary supplements Strong GMP/GDP knowledge and experience with FDA regulations (21 CFR 111, 117, 210, 211) and Quality Systems Hands-on experience with investigations, deviations, CAPAs, supplier qualification, and auditing Data-driven mindset with experience using metrics and statistical methods/Six Sigma tools Strong communication and cross-functional collaboration skills Ability to travel up to 25% domestically with occasional international travel Preferred Background Pharmaceutical industry experience strongly preferred (in-house or CDMO environment) Experience in fast-paced manufacturing or regulated environments Must be authorized to work in the

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