Overview
QA Technician role at Natus Medical Incorporated
Location: Gort, Co. Galway • Work Type: On site • Role Type: Full time permanent contract
Job Overview: A Quality Technician plays a critical role in ensuring adherence to the Quality Management system and GMP. This role supports 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 Responsibilities
* At 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 guiding principles and behaviours and actively participating in a culture that puts patients first, demonstrating teamwork, agility, accountability, and respect.
* 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, GMP, and regulations such as 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, 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 the collection of quality data for monitoring 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; 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 pension
* Excellent career progression opportunities
* Health Insurance & Life Assurance cover
* Educational 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.
EEO 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.
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