QA Technician

FOR MORE THAN 80 YEARS, Natus has been working in collaboration with clinicians to deliver industry-leading neuro solutions that help providers more easily make sense of the body’s signals.Engineered with input from those who have lived the care experience, our technology simplifies complex processes and improves accuracy and efficiency. There is a role for everyone who wants to be part of the innovative solutions at Natus Neuro.Quality TechnicianLocation: Gort, Co. GalwayWork Type: On siteRole Type: Full time permanent contractJob Overview:A Quality Technician plays a critical role in ensuring adherence to the Quality Management system and GMP. This role support our Gort facility and other Natus sites aboard a global team.Assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Facilitates internal training on quality assurance requirements, processes, and procedures. May perform internal audits and risk assessments.Key ResponsibilitiesAt support level, this role performs the full scope of departmental tasks independently and reliably. A Quality Technician is responsible for ensuring the quality of medical devices and processes according to strict regulatory standards. The role involves performing inspections, supporting quality systems, and assisting with continuous improvement initiatives within the company's manufacturing facilities. They apply broad job knowledge and skills across a wide range of assignments, with an understanding of how their work impacts interdependent departments, customers, or vendors. Work is completed with limited supervision, allowing for a high degree of independent decision-making.Contribute to the team's success by embracing our guiding principles and behaviours and actively participating in a culture that puts our Patient first.  You will demonstrate exceptional teamwork, agility, accountability, and respect, cultivating an environment where collaboration and continuous improvement thrive.Inspections and testing: Conduct inspections and tests on incoming raw materials, in-process products and finished goods/devices. This includes performing Device History Record (DHR) closures and product releases.Compliance: Maintain compliance with quality system requirements, Good Manufacturing Practices (GMP), and specific medical device industry regulations like FDA 21 CFR 820 and ISO 13485.Quality system support: Provide day-to-day quality support for various products, processes, and systems.Issue resolution: Support investigations into customer complaints, Corrective and Preventive Actions (CAPA), and issues related to non-conforming products.Training: Train manufacturing operators on inspection criteria, establish training samples, and create inspection standards.Continuous improvement: Contribute to initiatives that improve company systems and practices. Contribute to collection of quality data for monitoring of QMS processes and completing periodic GMP audits.Documentation control: Ensure procedures are updated to reflect current practises. Ensure DHRs are stored correctly to maintain traceability. Experience Required:A minimum of two years of related work experience, preferably within the medical device industry, is desired. Experience with product inspection/release techniques and Quality experience is a strong advantage.Excellent organizational, documentation, and communication skills.Strong working knowledge of standards such as MDR, ISO 13485, and FDA regulations is a plus.Ability to work independently and collaboratively in a fast-paced environment.Why Join Us?Be part of an innovative company shaping the future of healthcare technology.Work in a collaborative environment with opportunities for professional growth.Attractive salary package with pensionExcellent career progression opportunitiesHealth Insurance & Life Assurance coverEducational assistance Employee Rewards Program Compensation and Benefits: Along with a competitive salary and bonus structure, we offer a comprehensive benefit package to start: Health & Life Assurance cover, defined contribution pension plan, active sports and social club, flexible work location, flextime (depending on position), excellent career progression opportunities, free parking, and educational assistance.Be the Peoplepart of the Neuro Solution. Apply Today.#INDNATUSEEO Statement: Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.