Job Title: Quality Engineer
Located in Galway Business Park, Dangan, this role offers a competitive salary, 10% bonus, and share options.
About the Company:
My client is an early-stage medical device start-up company focused on designing and developing novel devices for treating Intracranial Atherosclerotic Disease.
Overview:
This position requires experience in quality assurance and quality & regulatory control of medical devices. You will focus on ensuring product quality from early development phases to commercialization.
Responsibilities:
* Ensure compliance with policies, procedures, national, and international regulations.
* Lead quality system improvement activities, such as CAPA, audit programs, and 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.
* Act as an audit escort and support during inspections.
* Provide expertise in quality assurance, controls, and systems to develop the company's Quality Management System (QMS).
* Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance.
* Work closely with suppliers to ensure robust quality agreements.
* Support internal teams in product development through first article inspection qualifications and test method development.
Requirements:
* Bachelor's degree in engineering or a related technical field.
* Minimum 2 years of experience in quality engineering within the medical device industry.
* Strong understanding of basic engineering principles.
This role offers an excellent opportunity to develop your experience and career in an exciting start-up helping develop a product from its very early stages.