Senior Quality Engineer (12-Month Fixed

at  Natus Medical Incorporated

ABOUT US:

At Natus Medical, we are a global leader in the development, manufacturing, and distribution of medical devices and software for a wide range of specialties, including neonatal care, neurology, sleep, hearing, and balance. With a focus on improving patient outcomes, we provide innovative screening, diagnostic, and treatment solutions to the medical community. Our Gort facility in Co. Galway plays a key role in manufacturing and distributing medical device products, specializing in the diagnosis of neurological disorders.

POSITION OVERVIEW:

We are seeking a Senior Quality Engineer to join our dynamic Quality Assurance team. This is a vital role that will directly contribute to the enhancement of our quality management systems, while ensuring compliance with industry regulations. The Senior Quality Engineer will work closely with product development teams, supporting design transfer activities, managing CAPAs (Corrective and Preventive Actions), and ensuring the highest standards of quality across our diverse product portfolio. This role offers an exciting opportunity for a skilled quality professional to drive process improvements and contribute to the success of our products.
Location: Gort, Co. Galway. This role can be hybrid (3 days onsite)

OUR IDEAL CANDIDATE WILL HAVE THE FOLLOWING QUALIFICATIONS AND SKILLS:

• A third-level degree in Science (e.g., Biopharmaceutical Science, Microbiology, Chemistry, or similar).
• 4-6 years of experience in microbiology or quality assurance within the medical device or pharmaceutical industry.
• Experience with design controls and design transfer processes, ideally within the medical device sector.
• In-depth knowledge of recognized Quality Management Systems (QMS) and Global Medical Device regulations (ISO 13485, ISO 14971, cGMP, CE, FDA, MDSAP, IVDR, PAL).
• Strong experience in managing CAPAs and supporting sterile product development.
• Excellent organizational skills with the ability to work autonomously.
• Strong communication skills (both written and oral) and the ability to work effectively within cross-functional teams.
• Fluent in English, both written and spoken.

• Ensure compliance with ISO 13485, 21 CFR 820, MDSAP, and other relevant regulations. Support the development and maintenance of quality management systems, ensuring that processes meet regulatory standards.
• Oversee cleanroom procedures (Class 8), environmental monitoring, and the sterilization program for sterile products, including dose audit programs.
• Provide quality engineering support to product development and sustaining teams, including design input/output, verification/validation, risk management, and design transfer activities.
• Take ownership of CAPA processes, ensuring issues are identified, tracked, and resolved in a timely manner, to drive continual improvement.
• Lead initiatives to streamline and improve quality systems and operational processes across the site. Support the implementation of lean quality practices and continuous improvement activities.
• Conduct internal audits, support external regulatory and corporate audits, and provide input into corrective actions as needed.
• Oversee product transfer activities, ensuring smooth transition of new products from development to manufacturing. Provide quality support for design updates and maintenance releases.
• Prepare and present quality metrics, trending data, and management reviews to ensure the continuous monitoring and improvement of quality performance.