Quality Engineer

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.

• •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

• •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

• •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 systems such as NCMRs, CAPAs, Defects & Scrap Rate, Complaints, Supplier Quality, Trainings etc.
• •Develops 4-blockers or presentations for key projects or quality issues when presenting to cross functional teams or site and senior leadership.
• •Leads Continuous Improvement of the products, processes and QMS via Kaizens, developing standard work and implementation of visual management.

• •Knowledge of statistical methods (SPC, MSA, DOEs, Six Sigma, Process Capabilities), statistical software (Minitab or equivalent) and Lean Manufacturing. ASQ or related professional certification(s) are a plus.
• •Familiarity with manufacturing process validation principles and risk-based approaches to quality assurance.
• •Understanding of Good Manufacturing Practices (GMP), ISO 13485, FDA QMSR, and related requirements.
• •Ability to interpret engineering drawings, technical specifications, and inspection requirements.
• •Proficiency in Microsoft Office applications, particularly Excel, Word, and familiarity with tools such as Power BI or equivalent. Familiarity with Python, Visual Basic or equivalent programing for data analysis is a plus.
• •Familiarity with testings such as Bioburden, TOC, Endotoxicity, Cytotoxicity etc. and sterilization process.

• •Strong analytical and problem-solving skills with attention to detail.
• •Ability to work independently, communicate and collaborate effectively across various departments, sister sites, suppli