Job Title: Process Excellence Engineer
We are seeking experienced professionals to support a site-wide remediation program following an FDA 483.
* Partner with process owners on the floor to identify and rectify 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.
Key Requirements:
* Bachelor's degree in Engineering or Quality discipline with 5-10 years' experience in med-tech.
* Background in remediation, process validation, CAPA, NCRs.
* Strong technical writing and documentation skills.
* Familiarity with 21 CFR Part 820, ISO 13485.
The ideal candidate will possess excellent analytical and problem-solving skills, with the ability to communicate effectively across departments.