Design Quality Assurance Specialist
We are seeking an experienced Design Quality Assurance Specialist to lead risk management activities and ensure compliance with regulatory standards. In this critical role, you will be responsible for maintaining documentation, performing statistical analysis, and collaborating with cross-functional teams to drive quality and innovation.
Key Responsibilities:
* Maintaining design control compliance across all projects
* Leading risk management activities (UFMEA, DFMEA, PFMEA) and ensuring accurate documentation
* Initiating corrective actions and supporting biocompatibility testing
* Validating test methods and measurement systems
To be successful in this role, you will require a degree in Engineering or a related field, along with 5+ years of experience in the medical device industry. Essential skills include:
* Strong knowledge of ISO 13485, ISO 14971, and relevant CFRs
* Detail-oriented and adaptable with excellent problem-solving skills
* Ability to manage multiple projects and collaborate effectively within a team environment
This is an exciting opportunity to work on cutting-edge medical technology and contribute to the development of innovative products that meet stringent safety and regulatory standards.