Vice President Quality & Regulatory Affairs

We are seeking a Vice President of Quality & Regulatory Affairs to lead quality and regulatory functions within a regulated medical device manufacturing environment. This individual will oversee the quality management system, ensure regulatory compliance, and build a culture of continuous improvement across the organization. The ideal candidate brings progressive quality leadership experience in a contract manufacturing or custom manufacturing environment, with the ability to balance hands-on quality oversight with executive-level strategic leadership. Key Responsibilities of the Vice President of Quality & Regulatory Affairs: Lead and continuously improve the Quality Management System (QMS) to ensure regulatory compliance and meet customer requirements. Oversee CAPA, nonconformances, root cause investigations, audits, and regulatory inspection readiness. Serve as the primary quality contact for customers, managing quality reviews, escalations, and compliance expectations. Partner with engineering and operations to support product development, process validation, manufacturing quality, and continuous improvement. Oversee regulatory activities and ensure quality systems remain aligned with evolving industry requirements. Lead, mentor, and develop the Quality & Regulatory team while promoting accountability and a strong quality culture. Contribute to executive-level decisions involving quality risk, customer relationships, operational performance, and business growth. Qualifications of the Vice President of Quality & Regulatory Affairs: Bachelor's degree in Engineering, Life Sciences, or a related technical discipline, or equivalent experience.10+ years of progressive quality experience in a regulated manufacturing environment, including at least 5 years in a leadership role. Strong working knowledge of ISO 13485, FDA quality system requirements, and applicable medical device regulations. Expertise in CAPA, nonconformance management, root cause analysis, auditing, inspection, calibration, and quality engineering. Experience leading quality functions in a contract manufacturing, custom manufacturing, or job shop environment. Ability to manage multiple customer requirements while maintaining consistent quality standards. Experience supporting or leading customer audits, regulatory inspections, or third-party certification audits. Strong leadership and communication skills, with the ability to collaborate across engineering, operations, and executive teams. Occupational Code: 11-3051.01 — Quality Control Systems Managers.