Job Summary:
We are seeking a seasoned Quality Systems Engineer to join our team. As a key member of the quality management group, you will be responsible for implementing and maintaining our company's Quality Management System.
Main Responsibilities:
1. Ensure that our Veryan Quality Systems comply with 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, ISO 14971 and Japanese Ministerial Ordinance #169.
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 & 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 a 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.