Job Description:
We are partnering with an early-stage medical device start-up company focused on designing and developing novel devices for the treatment of Intracranial Atherosclerotic Disease (ICAD).
The Role: This position requires a proven track record in Quality and Regulatory control of medical devices.
Responsibilities:
* Ensure product quality during early development phases through to commercialization
* Support Quality Management System (QMS) activities, batch release, internal audits, and supplier management
* Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
* Plan, execute, report, and follow up on quality system audits
You will work closely with suppliers to ensure robust quality agreements are in place, including periodic review of their quality metrics.
Key Responsibilities include:
* Providing expertise in quality assurance, controls, and systems to support and develop the QMS
* Developing and implementing control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements
* Gathering and analyzing data to support statistical rational sample testing requirements during early product development
Requirements:
* Bachelor's degree in Quality Engineering, Life Science, or related field
* 3-5 years of experience in a quality assurance role in the medical device sector, preferably in a FDA/MDR regulated environment
* Quality certification and lead Auditor certification advantageous
Please note that this is a confidential discussion, for more information contact Michelle Mc Inerney.