Quality Engineer

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.

Remote Work :

No

Employment Type :

Contract