Job title: Quality Engineer
Location:Galway Business Park, Dangan
Benefits:Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages.


Company:
My client 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.



Overview:
This position requires experienced and proven track record in Quality Assurance and Quality & Regulatory control of medical devices. This role will focus on ensuring product quality during early development phases through to commercial. Development and supporting Quality Management System (QMS) activities, batch release, internal audits, and supplier management



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 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, 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.
- Gather and analyze data 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



Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on 087 0612325 OR thomas.gallagher@lifescience.ie