Quality Engineer - Dallas, Texas

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 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.