Quality Engineer

Position Summary With a high degree of autonomy, the Quality Engineer will contribute to ensuring that production and process control activities are conducted in compliance with the company quality management system and the international regulations governing medical device manufacturing and distribution. The role evaluates non‑conforming products, analyzes data, proposes product disposition, initiates CAPAs, and communicates findings to manufacturers or develops process improvements. Responsibilities Support Quality Management for executing quality engineering activities related to design and manufacture of products in compliance with the Quality Management System requirements and applicable regulations. Collect and critically analyze data and take disposition decisions on non‑conforming products identified in production. Lead proper investigations to identify causes of component/product failures (nonconforming products from production and complaints). Generate risk evaluations for nonconforming products already distributed (Health Hazard Evaluation) to assist management in determining whether to stop shipment or initiate field action. Lead CAPA projects and trend data to identify opportunities for future CAPAs. Support external manufacturers of semi‑finished and finished products in managing any detected nonconformities, notifying suppliers of non‑conformance related to purchased material, and evaluating corrective action consistency versus internal controls. Establish product quality control inspection plans, review process validation planning, protocols, and reports. Preliminary review of change impact assessment to confirm quality requirements are met. Maintain Risk Management files and collaborate in investigations into the causes of V&V failures. Identify opportunities for quality improvements in the production area and lead improvement plans. Daily management of assigned complaint handling activities related to customer use of the device, evaluating and investigating complaints, and providing timely analysis to meet Customer Quality complaint and MDR reporting quality metrics. Lead effective meetings, conduct presentations, and establish quality records to support resolution of customer complaints. Develop effective relationships with internal personnel and external stakeholders to assist customers. Qualifications 1‑3 years of related experience in Class II/III medical device manufacturing or related regulatory industry. Knowledge of regulatory requirements (e.g., FDA, ISO13485). Experience with MDSAP and Medical Device Requirements is a plus. Proficiency with quality tools such as flowcharts, statistical data analysis, and mathematical reasoning. Experience with CAPA and ability to analyze and problem‑solve. Ability to work within a changing environment and engage a wide variety of personnel on all levels. ASQ Certified Quality Engineer or other ASQ certifications are a plus. Excellent written and verbal communication and presentation skills. Ability to communicate across functional lines. Physical Demands and Work Conditions Sitting 60‑80%, standing & walking 20‑40%. Repetitive work on computer 80%. Must be able to work in a clean room environment and tolerate chemical odors. Must be able to work in a lab environment and tolerate the smell and sight of blood. Education Bachelor’s Degree in Technical and Scientific disciplines (Engineering, Physics, Chemistry, or Biology). Benefits and Compensation Salary range: $85,000–$95,000 annually + annual bonus incentive. Travel Requirements: Occasional travel may be required. Equal Employment Opportunity LivaNova values equality and diversity. The company is committed to ensuring that the recruitment process is fair, transparent, and free from unlawful discrimination. Selection is based on key demands/requirements for the role rather than bias or discrimination on the basis of legally protected classifications. #J-18808-Ljbffr