About the job
The Senior Quality Engineer ensures adherence to applicable Quality Standards and Regulations and provides support on design transfer, production and post-production activities of ONWARD medical devices in compliance with our ISO13485 based QMS.
Responsibilities
Support our manufacturing engineering department on topics such as design transfer activities, manufacturing process validation, risk management and monitoring of manufacturing activities.
Support our development department by providing necessary inputs to achieve products design for manufacturing.
Support our supplier control and monitoring teams as necessary.
Support change control process related to change of products design or manufacturing.
Lead non-conforming product investigations and related topics like execution of CAPA and audit findings.
Release of products for commercial use or clinical studies.
Manage structural improvements in the QMS.
