Job Title

Aurora Lifesciences are proud to partner with an innovative Medical Device Company based in West Yorkshire to onboard their next critical hire for Quality Engineering Manager. This is an amazing opportunity to join a company that have developed a cutting edge medical device product where the market acceptance for the device has grown YoY.This role will involve the successful candidate to manage the day-to-day duties and priorities for the Quality Control and Quality Engineering teams. You will be proficient in utilizing continuous improvement techniques in conjunction with cross-site departments to streamline and simplify the Quality Management System processes and procedures.As Quality Engineering Manager you will manage and lead non-conformance investigations and document containment, root cause investigations. Furthermore you will provide technical leadership for a range of quality engineering activities including process change control, non-conformance investigations, SCARs, CAPA, quality continuous improvement projects and programs.Key ResponsibilitiesResponsible for tracking Quality Control and Quality Engineering key performance indicators, for performance and performs quality trend analysis for quality operations; develops scorecards to drive continuous improvement.Provides technical support for risk analysis for PFMEA and DFMEAs risk assessments associated with change, non-conformance and customer feedback as per the requirements of ISO 14971: 2019.Remain up to date with impending changes and developments regarding quality compliance requirements as per ISO13485 MDR 2017/745.Provides technical support for process validation (IQ, OQ, PQ) and qualification activities as per the requirements of ISO 13485 MDR 2017/745 and 21CFR820.Manage and provide technical support to Quality Engineering team to ensure that all processes are validated per the Validation Master Plan, applicable procedures, and regulatory requirements as per the requirements of ISO13485 MDR 2017/745.Responsible for receiving inspection processes.Required Experience Minimum of 6 years’ experience within a management and leadership role in an ISO13485 environmentWorking knowledge of European and US Quality System requirements (ISO13485 MDR 2017/745 and 21CFR820).Proven track record leading cultural change.Working knowledge of validations; nonconformance resolution; CAPA; and continuous improvement.Thorough knowledge of inspection first principle measurement techniques and quality engineering/assurance principles.Thorough knowledge of ISO14971 risk management of medical devices.Thorough knowledge of Lean principles and 6-sigma tools.Proven track record leading and managing teams, quality system and process improvement projects/ program, and driving change initiatives.Strong verbal and written communication & presentations skills; comfortable presenting to all levels of an organization.The Company are ISO13485 accredited so can only accept applications from those that have worked to this standard.