Quality Engineer at Globus Medical in Limerick, PA

Job description

Branch Medical Group, a subsidiary of Globus Medical Inc., manufactures a wide range of implants for spinal and orthopedic applications as well as design the instrumentation cases that house them. Our passion, combined with Globus’ world-class engineering, transforms clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care and understand that speed is critical because life cannot wait. At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. Position Summary The Quality Engineer supports musculoskeletal devices and instruments manufacturing operations through the development, implementation, and continuous improvement of quality systems, processes, and controls within a regulated medical device environment. Working collaboratively with cross-functional teams, this role applies engineering principles, statistical analysis, and risk-based decision-making to resolve quality issues, support process validation and manufacturing changes, and improve product quality and process efficiency. The position also supports regulatory compliance and overall Quality Management System. Key Responsibilities Manufacturing & Supplier Quality Support investigations and resolution of product, process and systems related quality issues (NCs) or deviations. Analyze manufacturing data to evaluate process performance, identify trends, develop and optimize inspection methods, sampling strategies, and process controls to improve product quality and manufacturing efficiency. Own supplier quality for respective areas or product lines – resolution of incoming quality issues, SCARs, supplier qualifications and supplier monitoring, supplier audits, supplier site visits and updates to supplier agreements. Evaluate changes to supplier processes and assess the impact on Globus Medical processes and products. Owns corrective and preventive action (CAPA) activities, including root cause analysis, corrective action implementation, and effectiveness verification. Process Validation & Risk Management Develop, execute, and maintain manufacturing process validation activities (IQ/OQ/PQ); maintain MVPs. Perform MSA (TMV and Gage R&R) studies to develop or optimize product inspections methods. Evaluate manufacturing process changes, equipment transfers, and new product introductions to determine appropriate qualifications and QMS impact. Participate in risk management activities such as risk assessments, Process Failure Mode and Effects Analyses (pFMEAs), and control plan development and maintenance. Collaborate with cross-functional teams to identify process risks, establish appropriate controls, and support the implementation of risk mitigation strategies. Reduce the overall risk and compliance gaps related to products, processes and QMS. Compliance, Continuous Improvement & Technical Leadership Provide technical guidance and quality engineering support to Manufacturing Engineering, Operations, Product Development, Quality Control, and other stakeholders. Communicate quality-related findings, risks, recommendations, and project updates to internal teams, management, customers, and suppliers, as applicable. Maintain accurate and timely records in accordance with established quality system requirements. Develop and improve quality management system procedures, work instructions, and control documentation. Support internal and external audits, including audit preparation, responses to findings, and corrective actions. Perform data analysis for various syste