Job Overview
We are seeking a skilled Senior Quality Engineer to drive the implementation of our quality management system and lead continuous improvement activities. The ideal candidate will support manufacturing, supply chain, and design assurance functions.
Main Responsibilities:
* Implement and lead continuous improvement of our quality management system.
* Develop and review test specifications, part specifications, and design specifications with cross-functional teams.
* Support manufacturing team activities in regulated environments, such as equipment qualification and process validation.
* Provide practical QA and Design Assurance expertise.
* Collaborate with the supply chain to ensure supplier-related activities meet requirements.
* Coordinate internal audit programs, material review boards, and complaint processes.
* Support regulatory submissions and clinical investigations.
Requirements:
* Bachelor's degree in engineering, science, or a related field.
* At least three years' experience in medical device quality/design assurance roles.
* Recent regulatory experience, including FDA regulations, ISO 13485, Medical Device Directive, and other applicable national and international regulations and standards.
About the Role
This is an exciting opportunity to join our organization and contribute to improving outcomes for individuals suffering from chronic heart conditions through advanced remote monitoring technologies. As a Senior Quality Engineer, you will have the chance to work collaboratively with cross-functional teams to drive quality and innovation.