Senior Quality Systems Engineer
As a Senior Quality Systems Engineer, you will play a pivotal role in the implementation and upkeep of our company's Quality Management System.
About Our Organisation:
* We are a rapidly growing Medical Device business based in Ireland. We have developed cutting-edge technology to enhance the performance of Vascular stents.
Key Responsibilities:
1. Ensure that our quality systems adhere to regulatory requirements, including the Medical Device Directive 93/42/EEC, Medical Device Regulation 2017/745, and ISO 13485.
2. Maintenance and continuous improvement of the quality management systems.
3. Act as Coordinator for CAPA, Complaints & Temporary Authorization (Deviations) processes to support the owners in meeting required timelines.
4. Review and approval of Non-conformance, CAPA, and Complaint investigation reports.
5. Act as Coordinator for the Audit Management Process.
6. Manage the annual audit schedule and coordinate internal and external audits as required.
7. Track audit actions from initiation to closure.
8. Coordinate activities in the preparation and management of audits by regulatory bodies.
9. Manage Quality Systems data collection and analysis to facilitate timely generation of Monthly Reports, Management Review data, etc.
10. Prepare and present data to management on quality system performance, including Monthly Quality Reports.
11. Generate Quality Systems data as required for Post Market Surveillance purposes.
12. Act as primary contact for other departments providing quality oversight to ensure compliance and promote quality improvements.
13. Provide quality review on a range of documentation including procedures, specifications, investigations, and other Quality Management System documentation as required.
Required Skills and Qualifications:
* Minimum 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 relevant experience in the medical device industry.
* Familiarity with 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.