Make a meaningful difference to patients around the world. Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimising product development to impact patients around the world with pioneering technology. The Role Lead Receiving Inspection Engineering and Inspection Operations to ensure incoming components and devices meet approved specifications, regulatory requirements and company quality standards. The role manages RI Engineers and the RI Supervisor, with overall accountability for Engineers and inspector performance, compliance, capability, capacity and continuous improvement. How Will You Make An Impact? · Lead RI Engineers and the RI Supervisor, setting clear priorities, objectives and accountability across the RI organisation. · Ensure safe, compliant and responsive execution of visual, dimensional and functional receiving inspection. · Provide oversight of inspection methods, measurement systems, equipment, validation and technical problem-solving. · Ensure inspection records, system transactions, material identification, segregation, storage and movement meet approved requirements. · Ensure nonconforming incoming material is identified, contained, documented, assessed and escalated in a timely, risk-based manner. · Own RI resource, capacity, training, qualification, cross-training, talent and succession plans. · Define and review metrics for safety, quality, compliance, service, capacity, productivity, ageing and right-first-time performance. · Lead projects and continuous-improvement initiatives that strengthen compliance, improve material flow and reduce inspection cycle time. · Partner with Operations, Supply Chain, Supplier Quality, Engineering and Quality Systems to resolve issues and support business priorities. · Maintain audit readiness and ensure effective implementation of changes involving new products, suppliers, components or inspection methods. · Delegate daily inspection execution and inspector coaching to the RI Supervisor while retaining management accountability. · Make risk-based priority and resource decisions within approved quality-system and business requirements. · Escalate significant quality, compliance, safety, capacity or material-flow risks. · Coach and develop the team, manage performance and employee relations with HR support, and build succession coverage. What You’ll Need? · Bachelor's degree in Science, Engineering or a related technical field, with relevant quality engineering, manufacturing quality or receiving inspection experience. · People-leadership experience in a regulated manufacturing environment; experience managing a supervisor is preferred. · Experience with inspection operations, measurement systems, technical drawings and specifications, including GD&T. · Experience supporting internal audits and external regulatory inspections in a medical-device or similarly regulated industry. · Demonstrated delivery of cross-functional projects and operational improvements. What Else We Look For? · Strong knowledge of quality engineering, receiving inspection, cGMP and applicable ISO/EN requirements. · Knowledge of inspection techniques, measurement-system principles, process capability, SPC, FMEA and statistical methods. · Ability to lead inspection-method and automated or vision-system development and validation. · Strong people, project, communication, negotiation, problem-solving and stakeholder-management skills. · Ability to use performance metrics, Lean and Six Sigma methods to improve compliance, service, flow and productivity. · Proficiency with Microsoft Office and relevant quality or manufacturing systems, such as JDE or equivalent. Success Measures · Safe, compliant and audit-ready RI operations. · Delivery against inspection demand and business priorities. · Timely management of incoming-material nonconformances and risks. · Capable, efficient inspection methods and equipment. · Clear accountability and effective hand-offs between engineers, the supervisor and inspectors. · Sustained team competency, development and measurable improvement in quality, service and flow. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

RI Engineering & Inspection Manager.

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