The Design Quality Engineer supports design iterations of products through the entire Product Lifecycle. These activities include leading Risk Management assessments, collaborating with development teams to establish appropriate testing plans, guide teams through Design Controls, ensure compliance to the Quality Management System.   

Key Responsibilities:  

The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position. 

• Drive quality focused design and development within the product’s development lifecycle by defining requirements, verification and validation plans and strategies while maintaining traceability 


• Lead and conduct risk management activities (FMEAs)


• Ensure that design controls are compliant to internal procedures as well as applicable external standards and norms 


• Support regulatory bodies submission of new products 


• Participate in design reviews 


• Review and approve design documentation


• Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA etc.), ISO 13485, ISO 14971, MDR and other national and international quality and regulatory requirements and standards 


• Support escalations and conduct technical investigations 


• Leading multidisciplinary projects and processes