Quality Project Leader

**Job Responsibilities:**
End to End Quality Engineering responsibility for Class 1 and IIA (class II) medical device product development
Instruct, coach and facilitate project teams on relevant product standards (IEC60601/ IEC60335/IEC60601/21 /ISO9001/ISO13485, etc.)
* Creates and executes comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision.
* Handles the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards.
* Keeps a check on the drafting and updating of detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements.
* Ensures success ...