Quality Engineer - Pharma Compliance & Process Improvement

MissionHires; Dallas (TX); On-site; USD 60,000 - 78,000; Full time

Job summary

MissionHires is seeking a Quality Engineer to support quality engineering, compliance, validation, supplier quality, and continuous improvement for MCCPDC manufacturing and wholesale distribution operations. This early-career role emphasizes adherence to FDA requirements and cGMP standards.

You will collaborate with cross-functional teams to maintain quality systems, participate in continuous improvement projects, and assist with documentation, audits, and training verification.

Qualifications

• Bachelor's degree in Engineering or life sciences; graduate degree preferred.
• 0–3 years of relevant quality or engineering experience in an FDA-regulated environment.
• Knowledge of FDA/USP requirements for sterile and non-sterile compounding.
• Working knowledge of cGMP, USP <797>, 21 CFR Part 211, and related regulatory guidelines.

Responsibilities

• Support Engineering, Production, and Supply Chain in maintaining compliance with manufacturing and wholesale regulations.
• Assist with deviation logging, initial complaint processing, CAPA tracking, and audit preparation.
• Execute and support engineering and validation activities under senior staff guidance.
• Review and help draft SOPs, product specs, batch records, and change controls.
• Support Quality Management System oversight for ACE program and training verification.

Skills

Quality engineering

FDA regulations

cGMP

Data analysis

Audit readiness

Documentation

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Engineering or life sciences

Graduate degree preferred

Tools

eQMS

MS Office

CAPA system

Job description

MissionHires is seeking a Quality Engineer to support quality engineering, compliance, validation, supplier quality, and continuous improvement for MCCPDC manufacturing and wholesale distribution operations. This early-career role emphasizes adherence to FDA requirements and cGMP standards.

You will collaborate with cross-functional teams to maintain quality systems, participate in continuous improvement projects, and assist with documentation, audits, and training verification.