Job Opportunity
This role is a critical position in the development of novel medical devices for the treatment of Intracranial Atherosclerotic Disease (ICAD).
Key Responsibilities:
* Ensure compliance with Policies and Procedures, National and International Regulations.
* Lead quality improvement activities associated with the quality system, including CAPA, audit programs, personnel training.
* Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
* Plan, execute, report, and follow up on quality system audits.
* Provide expertise in quality assurance, controls, and systems to support and develop the Quality Management System (QMS).
* Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements.
* Collaborate with suppliers to ensure robust quality agreements are in place, including periodic review of their quality metrics.
* Support internal teams in the development of products through first article inspection qualifications, test method development, and approval activities.
* Collect, analyze, and report key data related to product testing, supplier performance, and internal quality metrics.