Lodz, POL
4 days ago
EU-MDR Quality Team Leader
**The Quality Team Leader (CG50)** is responsible for developing and implementing a quality control framework to align with organizational goals and regulatory requirements, ensuring high product quality and compliance. The role leads the Quality Control team, overseeing quality EU-MDR control processes, and conducting root cause analysis to address critical issues. The role coordinates with cross-functional teams, utilizes advanced quality management tools, and reviews documentation. The role manages audits, establishes and monitors performance metrics, ensures equipment accuracy, and drives continuous improvement projects using Lean methodologies. **Your role:** + Implements quality control framework, ensuring alignment with overall organizational goals and regulatory requirements to maintain high standards of product quality and compliance. + Leads and manages the Quality Control team, guiding and mentoring them, actively contributing to employee selection, performance management, compensation management, career development, and overseeing operational processes. + Oversees the development, implementation, and maintenance of quality control processes, procedures, and systems to ensure consistent and reliable product quality across all stages of production. + Oversees thorough root cause analysis and leads problem-solving initiatives for critical quality issues, driving the development and implementation of effective corrective and preventive actions. + Effectively manages escalations by the right identification of involved stakeholders with keeping E2E accountability of Quality Control Team over the EU-MDR verification process. + Coordinates with cross-functional teams, including research and development, production, regulatory affairs, and supply chain, to integrate quality control measures into product design, development, and manufacturing processes. + Reviews and approves comprehensive quality documentation, including inspection records, validation protocols, audit reports, and regulatory submissions, ensuring accuracy and compliance with industry standards. + Oversees internal and external audits of processes, suppliers, and subcontractors to ensure adherence to quality management systems and regulatory standards, addressing and resolving any non-conformances. + Establishes and monitors key quality performance metrics and trends, generating strategic insights and presenting to executive leadership to inform decision-making and drive continuous quality improvement initiatives across the organization. + Ensures the calibration, validation, and maintenance of all quality control equipment and instrumentation, guaranteeing accurate and reliable data for high-precision quality assessments. + Leads and drives continuous improvement projects within the quality control department, applying Lean methodologies to optimize processes, reduce waste, enhance product quality, and achieve operational excellence. + Addresses difficult to moderately complex issues or problems, requiring the evaluation of identifiable factors, following established processes and operational policies in selecting methods and techniques for obtaining solutions and possesses working understanding of Corrective and Preventive Action (CAPA), applicable regulations, requirements, and standards. **Requirements:** + Bachelor's / Master’s degree in Industrial Engineering, Manufacturing Engineering or equivalent in Quality or Supply Chain or Finance environment. + Minimum 4 years of experience in areas such as Quality Control, Quality Assurance, Production, Manufacturing or equivalent. + Good leadership skills: influencing others, organizational sensitivity; + Experience in being a trusted advisor to market senior level, demonstrated ability to drive impact; **How we work together** We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. **About Philips** We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. * Learn more about our business. * Discover our rich and exciting history. * Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.
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