Job Title:
An Exceptional Quality Professional
About the Role:
* The successful candidate will be responsible for ensuring product quality throughout all stages of development, from initial conception to commercial release.
* This critical role focuses on adherence to established policies and procedures, as well as national and international regulations.
* The individual will lead compliance and improvement activities related to the quality system, including CAPA, audit programs, and personnel training.
* Key responsibilities include applying systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
* The chosen candidate will design, execute, report, and follow-up on quality system audits, act as an audit escort, and support the coordination of backroom activity during inspections.
* This position requires expertise in quality assurance, controls, and systems to support and develop the company's QMS.
* The successful candidate will develop and implement control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements.
* Collaboration with suppliers is essential to ensure robust quality agreements are in place, including periodic review of their quality metrics.
* Ongoing support will be provided to internal teams in the development of products through first article inspection qualifications, test method development and approval activities, and statistical rational sample testing requirements.
* Data analysis will be conducted to support statistical rational sample testing requirements during early product development and ensure compliance with product specifications, regulations, and internal requirements.
Requirements:
* Bachelor's degree in engineering or a related technical field.
* Minimum of 3 years of experience in Quality engineering within the medical device industry, preferably with neuro interventional devices.
* Strong understanding of basic engineering principles.