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? Quality point of contact for Global Supply Chain with select Suppliers and EMs as part of the Supply Base Optimisation Team ? Work at select Preferred Supplier and EM locations to ? Produce advanced quality planning documentation ? Conduct Process Capability Studies, ? Drive cost improvement with the use of PE tools ? Develop and manage First Article Inspections as required at suppliers or within company ? Develop supplier capability in risk assessment such as PFMEA ? Manage training and certification of operators and inspectors to CTQs with the suppliers as required ? Develop and implement efficient and effective inspection points and control plans at the supplier ? Actively support all defined External Manufacturing Quality Systems goals and objectives. ? Conduct on-site quality and process assessments at preferred and EM suppliers both to approve new suppliers and on an on-going basis ? Review, guide and approve Medical Device Validation of new/changed production processes in accordance with company requirements and ISO 13485 as required ? Design and validate Quality System processes where appropriate (CSV and Inspection Process) ? Resolve problems & eliminate constraints to ensure project and supply targets are met. ? Ensure suppliers continue to meet company Quality requirements with regard to PR120-009 compliance ? Generate Quality metrics on supplier performance and establish measures to monitor quality costs and cost avoidance ? Communicate and assure appropriate implementation of Quality Process Specifications (QPS), Quality Control Test Specifications (QCTS), and Raw Material Specifications (RMS) etc. ? Ensure effective and timely closure on all Supplier Failure Investigation Reports. ? Maintain standards of housekeeping & GMP requirements ? Represent the Source Quality function as required by management. ? Ensure that all Health, Safety and Environmental requirements are fulfilled.