Quality Project Leader

Job Title

Job Description

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 syste...