Negotiable
Overview
Aurora Lifesciences are partnering with an innovative Medical Device Company based in West Yorkshire to onboard a Quality Manager. This role involves managing day-to-day duties and priorities for the Quality Control and Quality Engineering teams. You will apply continuous improvement techniques with cross-site departments to streamline and simplify the Quality Management System processes and procedures. You will provide technical leadership for quality engineering activities including process change control, non-conformance investigations, SCARs, CAPA, and quality continuous improvement projects and programs.Key Responsibilities
Responsible for tracking Quality Control and Quality Engineering key performance indicators, performing quality trend analysis for quality operations, and developing scorecards to drive continuous improvement.Provide technical support for risk analysis for PFMEA and DFMEAs in relation to change, non-conformance and customer feedback as per ISO 14971:2019.Stay up to date with changes and developments regarding quality compliance requirements as per ISO 13485 MDR 2017/745.Provide technical support for process validation (IQ, OQ, PQ) and qualification activities as per ISO 13485 MDR 2017/745 and 21 CFR 820.Manage and provide technical support to the Quality Engineering team to ensure all processes are validated per the Validation Master Plan, applicable procedures, and regulatory requirements as per ISO 13485 MDR 2017/745.Responsible for receiving inspection processes.Required Experience
Minimum of 6 years’ experience in a management/leadership role within an ISO13485 environment.Working knowledge of European and US Quality System requirements (ISO13485 MDR 2017/745 and 21 CFR 820).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 Six Sigma tools.Proven track record leading and managing teams, quality system and process improvement projects/programs, and driving change initiatives.Strong verbal and written communication and presentation 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.Seniority level
Mid-Senior levelEmployment type
Full-timeJob function
Quality Assurance, Manufacturing, and EngineeringIndustries: Medical Equipment ManufacturingReferrals increase your chances of interviewing at Aurora Lifesciences by 2xWest Yorkshire, England, United Kingdom — 1 day ..... full job details .....
Negotiable