Job Summary:
We are seeking an experienced Senior Quality Systems Engineer to join our team in Galway. As a key member of our quality assurance group, you will play a vital role in implementing and maintaining our company's quality management system.
About the Role:
* You will be responsible for ensuring our quality systems comply with relevant regulatory requirements, including Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820 & 803, ISO 13485, and ISO 14971.
* You will work closely with our quality systems manager to maintain and continuously improve our quality management systems.
* You will act as coordinator for CAPA, Complaints, and Temporary Authorization (Deviations) processes to support owners in meeting required timelines.
* You will review and approve non-conformance, CAPA, and complaint investigation reports.
* You will coordinate activities in preparation and management of audits by regulatory bodies.
* You will manage quality systems data collection and analysis to facilitate timely generation of monthly reports.
Requirements:
* A minimum of five years' relevant experience in the medical device industry.
* Educated to diploma level in an engineering, science, or quality assurance discipline.
* Familiarity of ISO13485, ISO14971, Medical Device Regulation 2017/745, and FDA QSRs is required.
Benefits:
This is a fantastic opportunity to work as part of a supportive and collaborative team in our state-of-the-art facility in Galway. We offer hybrid working arrangements, competitive salaries, bonuses, pensions, and healthcare benefits.