Quality Engineer - FDA-Regulated Pharma & Compliance

MissionHires; Dallas (TX); On-site; USD 50,000 - 75,000; Full time

Job summary

MissionHires is seeking a Quality Engineer to support quality engineering, compliance, validation, supplier quality, and continuous improvement for MCCPDC operations. The role ensures adherence to site procedures, FDA requirements, state regulations, cGMP, and compounding standards across sterile and non-sterile processes.

The position collaborates with Engineering, Production, and Supply Chain, handling deviations, CAPAs, audits, document drafting, data analysis, and training verification.

Qualifications

• Bachelor's degree in Engineering or a life science discipline or equivalent experience.
• 0-3 years of quality/engineering experience in FDA-regulated environment.
• Knowledge of FDA and USP requirements for sterile and non-sterile compounding.
• Familiarity with cGMP, USP <797>, 21 CFR Part 211, and regulatory guidelines.

Responsibilities

• Support compliance with laws and regulations governing manufacturing and wholesale operations.
• Assist with deviation logging, initial complaint processing, CAPA tracking, and audits.
• Assist in engineering and validation activities under supervision.
• Draft and review SOPs, product specs, batch records, and change controls.
• Support QM System oversight for ACE program and training verification.
• Maintain supplier documentation and qualifications.

Skills

Quality engineering

Regulatory knowledge

Data analysis

Written & verbal communication

Cross-functional collaboration

Project management

Education

Bachelor's in Engineering or life sciences

Graduate degree preferred

Tools

eQMS

Job description

MissionHires is seeking a Quality Engineer to support quality engineering, compliance, validation, supplier quality, and continuous improvement for MCCPDC operations. The role ensures adherence to site procedures, FDA requirements, state regulations, cGMP, and compounding standards across sterile and non-sterile processes.

The position collaborates with Engineering, Production, and Supply Chain, handling deviations, CAPAs, audits, document drafting, data analysis, and training verification.