Quality Engineer - Dallas, Texas

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 on behalf of a fast-growing online pharmacy company to support quality engineering, compliance, validation, supplier quality, and continuous improvement activities for MCCPDC manufacturing and wholesale distribution operations. This early-career role helps ensure adherence to site procedures, FDA requirements, state regulations, cGMP standards, and applicable sterile and non-sterile compounding requirements.

Responsibilities

• Support Engineering, Production, and Supply Chain teams in maintaining compliance with laws and regulations governing manufacturing and wholesale operations.
• Assist with day-to-day quality and compliance activities, including deviation logging, initial complaint processing, CAPA tracking, and audit preparation.
• Execute and support engineering and validation activities under the direction of senior quality engineering staff.
• Review and help draft technical documentation, including SOPs, product specifications, batch records, and change controls.
• Support Quality Management System oversight for the ACE program and training verification activities.
• Gather, organize, and maintain documentation required to establish and manage approved suppliers.
• Collect, compile, and perform basic analysis of quality data, metrics, and trends.
• Maintain accurate, legible, complete, and cGMP-compliant records and documentation.
• Build effective working relationships with cross-functional teams.
• Participate in continuous improvement projects and assigned workstreams.
• Lead new projects and workstreams as required.

Requirements

• Bachelor's degree in Engineering, a life science discipline, or equivalent relevant experience; graduate degree preferred.
• 0–3 years of relevant quality or engineering experience in an FDA-regulated environment.
• Knowledge of FDA and USP requirements for sterile and non-sterile compounding.
• Basic understanding of aseptic filling, terminal sterilization, and pharmaceutical compounding concepts.
• Working knowledge of cGMP requirements, including USP <797>, 21 CFR Part 211, and applicable regulatory guidelines.
• Computer literacy and familiarity with electronic Quality Management Systems (eQMS).
• Strong data analysis, critical-thinking, and decision-making skills.
• Working knowledge of audit processes and audit readiness activities.
• Ability to uphold high quality and compliance standards without compromising customer expectations or regulatory requirements.
• Excellent written and verbal communication skills.
• Ability to work effectively in a collaborative environment with guidance and direction.
• Project management proficiency and/or experience with Operational Excellence methodologies preferred.
• Applicable industry or professional certification preferred.
• Regular and predictable attendance.
• Must be authorized to work without employer sponsorship; relocation assistance is not available.