Job Title: Quality Engineer
Overview
This position requires an experienced and proven track record in Quality Assurance and Quality & Regulatory control of medical devices.
Responsibilities
* Responsible for compliance with policies and procedures and applicable national and international regulations.
* Leads compliance and improvement activities associated with the quality system (e.g. CAPA, audit programs, personnel training).
* Apply thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
* Plan, execute, report and follow-up on quality system audits. Act as an audit escort and/or support in the coordination of backroom activity during inspections as required.
* Provide expertise in the areas of quality assurance, controls and systems to support and develop the company's 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, including periodic review of their quality metrics.
* Provide ongoing support to the 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 2 years of experience in Quality engineering within the medical device industry, preferably with neuro-interventional devices.
* Strong understanding of basic engineering principles.
About Us
My client is an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease.
This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention.
The company offers a competitive salary, 10% bonus, share options, and excellent opportunities to develop your experience and career in an exciting start-up helping develop a product from its very early stages.