Vice President of Quality

Our client is a dynamic, growing leader in the medical device industry where patient outcomes and product excellence drive every decision. We are seeking a visionary, uncompromising Vice President, Quality to serve as the ultimate champion for product reliability and operational excellence across all North American sites. In this pivotal role, you will provide end-to-end strategic leadership from initial concept and R&D through manufacturing, commercialisation, and post-market surveillance. Reporting directly to the NA President with a dotted line to the Global Head of Quality, you will harmonise regional quality management systems (QMS) with global frameworks, shifting quality from a compliance metric into a competitive business advantage. Key Responsibilities Quality Strategy & Culture: Define and execute the North American Quality strategy, embedding a culture of zero-defect engineering, continuous improvement, and total quality ownership across the organization. QMS Excellence: Implement, mature, and optimise global quality management systems and standards (FDA, ISO 13485, GMP) across NA manufacturing and distribution sites to guarantee the highest standards of safety and efficacy. Operational & Manufacturing Oversight: Partner with manufacturing and operations teams to monitor, measure, and elevate production quality metrics, ensuring absolute consistency and robustness in every process. Audit & CAPA Leadership: Lead internal and external regulatory audits, ensuring optimal preparedness, swift and thorough root-cause investigations of non-conformances, and the execution of robust CAPA frameworks. Lifecycle Quality Partnership: Collaborate closely with R&D, Operations, Commercial, and Service groups to embed quality-by-design principles, ensuring product reliability and structural risk mitigation from design to product sunset. Regulatory Alignment: Act as a critical technical advisor to regulatory affairs teams, ensuring that all submissions, 510(k) clearances, and post-market vigilance strategies are built upon flawless, defensible quality data. Team Stewardship: Mentor, guide, and inspire a matrixed regional Quality team, building advanced talent capability in statistical process control, risk management, and quality engineering. Requirements Experience: Minimum 15 years of experience in Quality management, including at least 10 years of senior leadership experience strictly within the medical device industry. Education: Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or a related technical field. An advanced engineering or technical degree is strongly preferred. Technical Expertise: Comprehensive mastery of medical device quality standards (ISO 13485, FDA QSR, GMP) and a proven track record of designing, implementing, and measuring complex quality performance metrics. Soft Skills: Superior communication, critical thinking, and matrix-management capabilities. Must excel at advocating for quality principles across global, cross-functional teams and managing multi-time-zone coordination. Systems (Preferred): Familiarity with enterprise quality and manufacturing systems like SAP is a plus. #J-18808-Ljbffr Weber & Company