Senior Quality Systems Engineer Role:
The position of Senior Quality Systems Engineer is a key role within our organization, responsible for the implementation and maintenance of our Quality Management System. This individual will work closely with the Quality Systems Manager to ensure compliance 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.
The successful candidate will have a minimum of five years' experience in the medical device industry, with familiarity of ISO 13485, ISO 14971, Medical Device Regulation 2017/745, and FDA QSRs. They will possess strong analytical and problem-solving skills, with the ability to manage multiple projects simultaneously and prioritize tasks effectively.
Responsibilities include:
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* Ensuring Veryan Quality Systems are compliant with regulatory requirements
* Maintenance and continuous improvement of quality management systems
* Acting as Coordinator for CAPA, Complaints & Temporary Authorization (Deviations) processes
* Review & approval of Non-conformance, CAPA and Complaint investigation reports
* Acting as Coordinator for Audit Management Process
* Managing audit actions from initiation to closure
* Coordinating activities in preparation and management of audits by regulatory bodies
* Managing Quality Systems data collection and analysis to facilitate timely generation of Monthly Reports, Management Review data etc.
* Preparing and presenting data to management on quality system performance, including Monthly Quality Reports
* Generating Quality Systems data as required for Post Market Surveillance purposes
* Providing quality review on range of documentation including procedures, specifications, investigations, and other Quality Management System documentation as required