Quality Engineer

## Company Description ***QRC Group, LLC*** *is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.* *Log on now to our website http://www.**qrcgroup.com**/ to learn more about our services and solutions!* ## Job Description 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. Selected candidates may support QA oversight, protocol review and approval, CAPA, deviation investigations, remediation activities, clean-room/sterile manufacturing projects, equipment relocation, and regulatory compliance documentation. Role Summary Provide Quality Assurance / Quality Engineering support for quality, compliance, remediation, and project initiatives at a regulated pharmaceutical / medical device manufacturing site. Responsibilities may include QA oversight, protocol and documentation review and approval, signing documents on behalf of Quality Assurance, CAPA, deviation investigations, remediation activities, clean-room/sterile manufacturing support, equipment relocation, and regulatory compliance documentation. Key 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, including 21 CFR 210/211 and/or 21 CFR 820 as applicable. - 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 - 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 What We Offer - Opportunities for learning, development, and professional growth. - A collaborative and supportive work environment. - The opportunity to work with industry-leading clients on impactful projects. Your information will be kept confidential according to EEO guidelines.