Senior Quality Engineer - Med Device, FDA-Regulated

JobDiva, Inc. urgently seeks a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing. You will lead quality engineering efforts, manage transfers and validation activities, and ensure compliance with PFMEA, CAPA, and ISO 13485 requirements.

Ideal candidates have extensive experience with IQ/OQ/PQ validation, FDA 21 CFR Part 820, and robust technical writing skills to maintain compliant documentation and support audits.