Senior Quality Assurance Lead
We are seeking an experienced Senior Quality Assurance Lead to oversee the implementation and continuous improvement of our quality management system (QMS).
The ideal candidate will have a strong understanding of regulatory requirements, technical knowledge, and leadership skills.
Key Responsibilities:
* Oversight of QMS daily operations and strategic planning.
* Collaboration with R&D for the development and review of technical documentation.
* Quality assurance support for regulated manufacturing, including equipment qualification and process validation.
* Management of critical quality processes, including internal audits and complaint handling.
Essential Skills & Experience:
* Bachelor's Degree in Engineering, Science, or a related field.
* Minimum of 5+ years' recent experience in a Medical Device Quality or Design Assurance role.
* Strong expertise in FDA regulations, ISO 13485, and European Medical Device Directives.
Desirable Experience:
* Masters degree in a related field.
* Direct experience with implantable medical devices or complex process development in a highly regulated environment.