Quality Engineer

About the role

We are seeking QA / Quality Engineering professionals to support multiple quality, compliance, remediation, and capital project initiatives at a regulated pharmaceutical / medical device manufacturing site.

Responsibilities

• Provide QA oversight for assigned quality, compliance, remediation, and project work.
• Review, approve, and sign protocols, reports, manufacturing documentation, change-control documentation, and project documentation on behalf of Quality Assurance.
• Respond to technical and compliance questions from project, engineering, manufacturing, and cross-functional teams.
• Support deviations, root-cause analysis, non-conformances, CAPA, and complaint handling in accordance with site procedures and applicable regulatory requirements.
• Support clean-room, sterile, aseptic, Grade C/D, environmental monitoring, bioburden, contamination-control, and cleaning-validation activities as applicable.
• Support equipment relocation, facility qualification, remediation activities, and quality-system documentation as applicable.
• Ensure remediation activities and quality documentation are completed in accordance with regulatory and internal requirements.
• Collaborate with cross-functional teams, including manufacturing, engineering, R&D, regulatory affairs, complaint handling, and supply chain, as applicable.

Qualifications and applicable FDA requirements

• Experience with protocol review and approval, QA oversight, documentation review, deviations, root-cause analysis, CAPA, and quality-system documentation.
• Strong technical-writing, analytical, and problem-solving skills.
• Ability to work on-site in El Paso, Texas.
• Bilingual English/Spanish.
• Preferred qualifications include:
• Experience with sterile, aseptic, or combination drug-device manufacturing.
• Experience with Grade C/D clean-room operations, environmental monitoring, bioburden, contamination control, or cleaning validation.
• Knowledge of ISO 13485 and ISO 14971.
• Experience with CAPA, remediation, non-conformance management, regulatory findings, complaints, or field issues.
• Experience with TrackWise or similar electronic CAPA / quality systems.
• Experience with DHF, Risk Management Files, test method validation, sampling plans, SPC, FMEA, or quality-engineering tools.
• CQA or CQE certification.
• Experience in FDA remediation, Warning Letter, or Consent Decree environments.

Additional Information

Benefits: Opportunities for learning, development, and professional growth. A collaborative and supportive work environment. The opportunity to work with industry-leading clients on impactful projects.