Our client is a leading global company based in the Canton of Vaud, Switzerland, specializing in the development of high-precision medical devices. With a strong focus on innovation, quality excellence, and regulatory compliance, the company is committed to advancing patient care through cutting-edge technologies. They have built a reputation as a trusted partner for healthcare professionals worldwide and continue to drive growth across international markets. As part of their expansion, they are looking for a Head of Quality to further strengthen their operations and continue to ensure the delivery of high-quality, compliant medical devices. Your Mission As the Head of Quality & Regulatory Affairs, you will: - Lead with Purpose: Be the driving force behind the strategic development and execution of the Quality Policy and Management System, aligned with ISO 13485, FDA QSR 21 CFR 820, and other global standards. - Ensure Excellence: Spearhead quality assurance for product development, manufacturing, and market release while maintaining compliance with regulatory requirements. - Shape the Future: Develop and implement strategies to uphold the reputation for product reliability as new products are launched and the company expands into new regions. - Inspire and Motivate: Lead, mentor, and grow a high-performing quality team to meet the company’s ambitious goals. Key Responsibilities Strategic Leadership - Act as the Management Representative and Person Responsible for Regulatory Compliance (PRRC), ensuring robust quality systems and regulatory adherence. - Collaborate with cross-functional teams to support the seamless launch of new products and geographic expansion. - Define and implement a forward-thinking regulatory strategy to support business growth across all units. Operational Excellence - Establish and enhance quality systems, ensuring continuous improvement and alignment with global standards. - Manage third-party audits (ISO, FDA) and lead internal and supplier quality audits. - Oversee product compliance, risk management, and supplier validation to ensure product reliability and customer satisfaction. Team Development - Lead and inspire the quality team, fostering a culture of accountability, innovation, and excellence. - Provide training and promote regulatory awareness across the organization to build quality-conscious teams. Performance Management - Analyze quality-related data, oversee non-conformity resolutions, and drive corrective actions to improve product quality and minimize costs. - Report on key performance indicators (KPIs) and present findings to top management. Customer and Market Focus - Partner with internal stakeholders to address client quality concerns and ensure post-market surveillance compliance. - Support global growth by facilitating quality systems for new warehouses and country launches. What We’re Looking For: - Proven experience in quality management within the medical device industry or a regulated healthcare environment. - Expertise in ISO 13485, FDA regulations, and risk management methodologies. - Strong leadership skills, with a history of building and inspiring high-performing teams. - Strategic thinker with a hands-on approach to problem-solving and process improvement. - Exceptional communication skills and the ability to collaborate across diverse teams and functions. - Academic background: Master’s degree or engineering qualification in a relevant field (e.G., engineering, quality management, life sciences, or similar). #J-18808-Ljbffr