Quality Engineer
USA Jobs
Quality Engineer
WillowWood Global, a leading manufacturer of prosthetic devices, is looking for a Quality Engineer to join the Quality team at our manufacturing facility in Mt. Sterling, Ohio. The Quality Engineer is responsible for ensuring quality and regulatory requirements are met for all WillowWood products. The Quality Engineer will maintain Quality Management System records for ISO 13485:2016 and Medical Device Directive/Regulation, and FDA for Class I and Class II products and procedures.
Supports the mission, values and vision of WillowWood
Have and maintain knowledge of current regulatory requirements and standards related to the development, required documentation, and release of medical devices, including ISO 13485, FDA, and Medical Device Regulation (MDR)
Maintain a robust quality management system (QMS) that ensures compliance with all medical device regulations and safety standards across multiple sites for Class I and Class II mechanical, electronic, and software products
Support long-term quality, regulatory and compliance policies for worldwide markets.
Develop and support product development and design transfer activities by implementing standardized quality centric launch practices to enable business strategies.
Support the maintenance of the associated product Technical Files
Manage the review and approval of finished products manufactured for and by the company in accordance with their approved specifications
Manage document control procedures