**Senior Quality Assurance Professional**
We are seeking an experienced Senior Quality Engineer to join our team in a pivotal growth phase. Our company is preparing to commercialize a novel product and build out operational infrastructure to support rapid scaling.
This role requires a 'quality-first' mindset and proven ability to manage complex compliance requirements across multiple external vendors.
The ideal candidate will have deep expertise in Operations Quality and New Product Introduction (NPI), with strong knowledge of Design Controls, Process Validation, Production Controls, Risk Management, CAPA, and Supplier Quality.
Key Responsibilities:
* Serve as the core Quality contact assessing manufacturing contractor's processes meeting all quality controls.
* E nsure comprehensive compliance with FDA QSR (21 CFR Part 820), ISO 13485, EU MDR, and ISO 14971 (Risk Management) across global markets