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Quality Engineer
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- The Quality Engineer acts as the primary contact for operations on all quality issues.
- They assure Value Stream activities remain in compliance with FDA/ ISO regulations/ standards/ guidelines, facility SOPs and Policies, and customer requirements, supporting organizational Quality/ Business Goals and Objectives while providing team leadership support for process improvement projects, namely quality and productivity increases, and cost and scrap reductions.
- Follow and comply with FDA Quality Systems Regulations, ISO Standards and SOPs as defined by Viant Medical’s policies and procedures.
- Initiates writing necessary documents needed for product launch such as MVP Master Validation Plan and Component Risk Protocol
- Assists in the assessment of Viant’s Supplier Development Program; addresses problems and recommends solutions to supplier quality; interfaces as necessary to ensure product specifications are met
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