Senior Quality Engineer

Essential Duties and ResponsibilitiesSupervise and coordinate Quality team activities, ensuring compliance with quality standards, regulatory requirements, corporate policies, Good Manufacturing Practices (GMP), and the organization's quality culture.Provide technical leadership, training, mentoring, and performance management for Quality Engineers under their responsibility.Identify gaps within the Quality Management System and ensure the timely implementation and follow-up of corrective and preventive actions.Participate in and provide support during internal audits, customer audits, corporate audits, and regulatory inspections.Lead and drive continuous improvement initiatives aimed at optimizing processes, reducing risks, and strengthening the effectiveness of the Quality Management System.Participate in Material Review Board (MRB) meetings to evaluate, analyze, and disposition nonconforming materials.Coordinate and ensure timely and effective responses to Customer and Supplier Corrective Action Requests, meeting established deadlines and requirements.Collaborate in the development, execution, and approval of validation protocols and reports, including IQ, OQ, PQ, and Test Method Validations (TMVs).Work closely with cross-functional teams to ensure customer quality requirements are incorporated and maintained throughout the product lifecycle.Ensure the qualification of new suppliers and the proper validation and release of new materials used in manufacturing processes.Analyze key quality performance indicators (KPIs) to identify trends, improvement opportunities, and potential business risks.Participate in quality investigations, root cause analysis, CAPA management, and problem-solving activities related to products and processes.Support the development and implementation of inspection methods, measurement systems, and equipment used in manufacturing processes.Ensure compliance with risk management requirements in accordance with ISO 14971 and other applicable regulatory standards.Maintain effective communication with internal and external customers to ensure timely resolution of quality-related issues.Perform other duties and responsibilities as required to support business needs.
Essential RequirementsBachelor's Degree or Licentiate Degree in Industrial Engineering, Materials Engineering, Chemical Engineering, Electromechanical Engineering, or a related field.Minimum of 5 to 8 years of experience in Quality functions within the medical device industry or other highly regulated environments.Experience in the implementation, maintenance, and continuous improvement of Quality Management Systems in compliance with ISO 13485.Knowledge and experience in the application of FDA QSR 21 CFR Part 820, 21 CFR Part 11, and ISO 14971 requirements.Experience in medical device risk management and risk analysis methodologies.Experience with Gage R&R studies, Measurement System Analysis (MSA), and statistical quality tools.Experience participating in internal audits, customer audits, and regulatory inspections.Experience conducting quality investigations, CAPA management, root cause analysis, and problem-solving activities.Experience leading continuous improvement projects and working with cross-functional teams.Advanced English proficiency (C1-C2).
Preferred Requirements:Knowledge of Operational Excellence (OpEx), Lean Manufacturing, or Six Sigma methodologies.Ability to manage and prioritize multiple projects, tasks, and objectives simultaneously.Strong teamwork orientation and ability to collaborate effectively with cross-functional teams.Proactive and results-driven mindset with a focus on continuous improvement.Excellent listening, communication, and influencing skills.Ability to build effective interpersonal relationships across all levels of the organization.Experience using ERP systems for transaction processing, data retrieval, and report generation.