Role: Senior Quality Systems Engineer
Location: Parkmore, Galway (Hybrid working)
Benefits: Top salary, hybrid working, bonus, pension and healthcare


Company:
My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore. They have developed an innovative new technology to improve the performance of Vascular stents.



Role:
Reporting to the Quality Systems Manager, as a Senior Quality Systems Engineer you will play a key role in the implementation and maintenance of the company’s Quality Management System.This is a fantastic opportunity, which will allow you to work as part of a supportive, collaborative team in our state-of-the-art facility here in Galway.



Responsibilities:

• Ensure the Veryan Quality Systems are compliant with, the 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, ISO 14971 and Japanese Ministerial Ordinance # 169.
• Maintenance and continuous improvement of the quality management systems.
• Act as Coordinator for CAPA, Complaints & Temporary Authorization (Deviations) processes to support the owners in meeting required timelines.
• Review & approval of Non-conformance, CAPA and Complaint investigation reports.
• Act as Coordinator for the Audit Management Process. Manage the annual audit schedule and coordinate internal and external audits as required. Track audit actions from initiation to closure.
• Coordinate activities in the preparation and management of audits by regulatory bodies.
• Manage Quality Systems data collection and analysis to facilitate timely generation of Monthly Reports, Management Review data etc.
• Prepare and present data to management on quality system performance, including Monthly Quality Reports.
• Generate Quality Systems data as required for Post Market Surveillance purposes.
• Act as a primary contact for other departments providing quality oversight to ensure compliance and promote quality improvements.
• Provide quality review on a range of documentation including procedures, specifications, investigations, and other Quality Management System documentation as required.

• Educated at a minimum to a Diploma Level in an Engineering, Science, or Quality Assurance discipline.
• Training/Qualification in Quality Systems, Complaints and CAPA is highly desirable.

• A minimum of five years’ relevent experience in the medical device industry.
• Familiarity of ISO13485, ISO14971, Medical Device Regulation 2017/745 and FDA QSRs is required.
• Experience in management of Quality Systems activities, in particular Complaints and CAPA is desirable.