Quality Engineer Role
We are seeking a motivated Quality Engineer to drive our Quality Management System (QMS) and support key manufacturing activities.
Key Responsibilities:
* Lead QMS Implementation: Drive the daily implementation and continuous improvement of the Quality Management System (QMS).
* Design Assurance: Collaborate with R&D to develop and review essential technical documentation, including test specifications, part specifications, and design specifications.
* Manufacturing Support: Provide QA support for regulated manufacturing, including equipment qualification, process validation, and change control.
* Compliance & Audit: Coordinate and manage critical quality processes, including internal audit programme, Material Review Board, NC/CAPA reviews, and complaint process.
* Regulatory & Supply Chain: Interpret relevant international standards (ISO 13485, FDA, MDR) to ensure compliance. Support supply chain team with supplier development and manufacturing requirements.
* Project Support: Provide quality expertise for regulatory submissions and clinical investigations.
Required Skills & Experience:
* Education: Bachelor's Degree in Engineering, Science, or related field.
* Experience: Minimum 5+ years' recent experience in Medical Device Quality or Design Assurance role.
* Regulatory Expertise: Strong, recent experience interpreting and applying major regulations, including FDA regulations, ISO 13485, and European Medical Device Directives.
* Skills: Exceptional attention to detail, strong analytical and problem-solving abilities, and aptitude for identifying and implementing process improvements.
* Team Player: Excellent communication and influencing skills with proven ability to collaborate effectively across R&D, Manufacturing, and Supply Chain teams.
Bonus Experience:
* A Master's degree in related field.
* Direct experience with implantable medical devices or complex process development in highly regulated environment.