Job Overview
We are seeking a Senior Quality Engineer to join our team. As a key member of the quality function, you will be responsible for driving the day-to-day implementation of our Quality Management System (QMS) and supporting manufacturing, supply chain, and design assurance activities.
The ideal candidate will have a strong background in medical device quality/design assurance and recent regulatory experience including FDA regulations, ISO 13485, Medical Device Directive, and other applicable national and international regulations and standards.
* Main Responsibilities:
* Implement QMS processes and procedures to ensure compliance with regulatory requirements
* Support manufacturing team activities in a regulated environment, including equipment qualification, process validation, and change control
* Develop and review test specifications, part specifications, and design specifications with cross-functional teams
* Collaborate with wider teams to ensure necessary QA activities are planned, executed, and documented
* Provide practical QA and Design Assurance expertise
* Support supply chain in supplier-related activities, including process development and manufacturing requirements
* Coordinate and manage key activities such as internal audit programs, material review boards, NC/CAPA review boards, complaint processes, and project support for regulatory submissions
Qualifications and Experience:
* Bachelor's Degree in Engineering, Science, or related field
* 3+ 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
* Desirable: Master's degree in Engineering, Science, or related field; experience in implantable medical devices; experience with process development and change management in regulated environments