Senior Quality Systems Engineer "> The role of Senior Quality Systems Engineer is a key position within the organization, responsible for ensuring compliance with various regulatory directives and maintaining the quality management system. "> Key Responsibilities: "> "> * 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. "> "> "> Requirements: "> 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. "> 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. "> Benefits: "> Bonus, pension, healthcare, hybrid working. "]]