Job Description
Nordson Medical, a global leader in the medical device industry, is seeking an experienced and highly motivated individual to join our team in Galway, Ireland as a Senior Quality Engineer. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment.
Summary of the role
The Senior Quality Engineer will be working as part of a team to maintain high quality / performance standards on all Nordson Medical products while maintaining compliance with International Medical device standards and the Nordson Medical Quality Management System.
Reporting to the Quality Manager, the Senior Quality Engineer is a member of the Quality & Regulatory Affairs Department.
Role and Responsibilities
* Working with the operations and engineering teams to deliver on all KPIs that help the business achieve its goals.
* Implementation and management of monitoring systems in the production areas through automated use of the company’s ERP system, and best-in-class inspection techniques.
* Driving the company towards data-driven decision making.
* The senior quality engineer will perform an active role in further development and continuous improvement of the quality management system.
* Offer quality guidance to a team of Quality Technicians in support of the day-to-day manufacturing operations and driving to ensure that each of the balloon catheter, deliver system and component manufacturing lines/areas are operating at a world-class manufacturing standard.
* Overall responsibility for production GMP standards and compliance.
* Establishing inspection standards, sampling plans and test methods.
* Investigation of root cause and implementation of effective corrective actions to prevent re-occurrence of compliance issues.
* Establish and maintain risk management principles and methods throughout the product realisation process in compliance with the company’s Quality Management system and ISO14971.
* Maintain relevant documentation to comply with quality standards and customer requirements.
* Develop strong links with customer organisation’s and other project stakeholders.
* Quality review of responsible area validation documentation.
* Leading / supporting customer audits and surveillance / accreditation audits.
* Conducting audits of the manufacturing operation and the Quality system ensuring compliance with ISO13485.
* Support Operations area projects and initiatives i.e. Kaizen, data analysis, problem solving tools, etc.
Skills and Qualifications
* Degree in Quality or Degree in Science / Engineering.
* Experience within a similar role as a senior quality engineer.
* 5+yrs industry experience in a medical device-manufacturing or pharmaceutical environment.
* Working knowledge of FDA/ISO/MDD Quality systems for Medical device companies.
* Quality experience in component and device manufacturing desirable.
* Excellent written and oral communication skills essential.
* Process Monitoring / Statistical Process Control Experience desirable.
* Design and Development experience advantageous but not essential.
About Nordson Medical
At Nordson Medical, we value diversity and inclusivity in all aspects of our business. We are an equal opportunity employer and welcome candidates of all backgrounds, experiences, and perspectives to apply.
We are committed to ensuring a fair and equitable interview process, and our recruitment process is designed to identify the best qualified candidates for the role. We are looking for candidates who have a passion for inclusion, diversity and equity, and the ability to contribute to a culture where all employees feel valued, respected, and included.
Interested?
If you are interested in being a part of a team that is dedicated to improving the lives of patients through innovative medical technology and creating an inclusive and diverse workplace, please apply online with your CV.
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