Job Title: Quality Engineer
This is an exciting opportunity to develop your experience and career in a dynamic start-up company.
The role requires experienced professionals with a proven track record in Quality Assurance and Quality & Regulatory control of medical devices.
About the Company
Our client is an early-stage medical device start-up company focused on designing and developing novel devices for the treatment of Intracranial Atherosclerotic Disease.
Responsibilities
* Ensure compliance with policies, procedures, national and international regulations;
* Lead compliance and improvement activities associated with the quality system (e.g. 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 companies QMS;
* Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements;
* Work closely with suppliers to ensure robust quality agreements are in place;
* Support internal teams in product development through first article inspection qualifications and test method development and approval activities;
Requirements
* Bachelor's degree in engineering or a related technical field;
* Minimum of 2 years of experience in Quality engineering within the medical device industry, preferably with neuro interventional devices;
* Strong understanding of basic engineering principles.