Job Title: Quality Assurance Specialist
At our medical device start-up company, we are seeking an experienced Quality Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring product quality during early development phases through to commercial. This role requires strong understanding of basic engineering principles, quality assurance, and regulatory compliance.
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Responsibilities:
* Lead compliance and improvement activities associated with the quality system (e.g., CAPA, audit programs, personnel training).
* 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, including periodic review of their quality metrics.
* Provide ongoing support to internal teams in the development of products, through first article inspection qualifications, and test method development and approval activities through to commercial.
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.
Benefits:
* Competitive salary.
* 10% bonus.
* Share options.
About Us:
This is an exciting opportunity to develop your experience and career in an evolving treatment area likely to be the next frontier in Neuro-intervention.