Quality Engineers

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.

Requirements

Required Qualifications

Bachelor’s degree in Engineering, Life Sciences, or a related field.

Minimum 5 years of QA, Quality Engineering, or quality management experience in a regulated pharmaceutical or medical-device environment.

Working knowledge of cGMP 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.