SUMMARY

Veryan Medical is a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. We share a commitment, a passion, and a vision for the contribution Veryan makes to innovation in interventional medicine.
Our team powers Veryan’s business. Whether sales representatives, design engineers, quality engineers, or clinical study managers, our people bring an unmatched expertise in each of their fields that both inspires and challenges.
Veryan’s culture of innovation helps each individual develop both professionally and personally, and our culture of respect means that we all work in a collaborative, empowering, and exciting environment. We are committed to excellence through our patient-centric approach, and we pride ourselves in our integrity of doing what is right and doing what we say.
Reporting to the Quality Systems Manager, the Quality Systems Engineer will play a key role in supporting the implementation and maintenance of the company’s Quality Management System. This is a fantastic opportunity, which will allow the successful candidate to work as part of a supportive, collaborative team in our state-of-the-art facility here in Galway.

EDUCATION & TRAINING

• 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.

EXPERIENCE & SKILLS

• A minimum of two years’ relevent experience in the medical device or pharmaceutical industry is required.
• Familiarity of ISO13485, ISO14971, Medical Device Regulation 2017/745 and FDA QSRs is desirable.
• Excellent attention to detail, communication skills, organisational skills, people and team working skills.
• Experience in management of Quality Systems activities, in particular Complaints and CAPA is desirable.

• 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.
• Support the maintenance and continuous improvement of the Veryan 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.
• Support activities in the preparation and management of audits on Veryan, by regulatory bodies.
• Support 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.
• Coordinate activities relating to Software validation process at Veryan.
• Support activities associated with Supplier Management Approval. This includes supplier selection, approval, monitoring and reporting.
• Support the Management Review process. This includes scheduling management reviews, driving the assimilation of management review data, compiling management review presentations, documenting the actions items, and ensuring thorough and timely closure of management review action items.
• Actively participate in assigned projects.