Medical Device Quality Engineer Role
We are seeking a seasoned remediation quality engineer or manufacturing engineer to join our site-wide remediation program following an FDA 483.
* This role involves focusing on manufacturing process validation, quality system updates, and documentation remediation.
* As part of the team, you will work directly with manufacturing and quality process owners to identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready.
* Remediate areas in sequence, update technical files and procedures, and ensure robust validation of manufacturing processes.
Main Responsibilities:
* Partner with process owners on the floor to capture and remediate issues.
* Support process validation (IQ/OQ/PQ) and documentation updates.
* Drive CAPA/NCR closure and implement compliant solutions.
* Provide technical writing for quality and manufacturing documents.
* Collaborate cross-functionally to ensure regulatory compliance.
Requirements:
* An engineering or quality degree with 5-10 years' med-tech experience.
* A background in remediation, process validation, CAPA, NCRs.
* Strong technical writing and documentation skills.
* Knowledge of 21 CFR Part 820, ISO 13485.