Vice President of Quality & Regulatory Affairs

The Company is seeking a Vice President of Quality & Regulatory Affairs to lead quality and regulatory functions in a regulated medical device manufacturing environment. Responsibilities include overseeing and continuously improving the quality management system, maintaining regulatory compliance, and ensuring customer requirements are met. The role leads CAPA, nonconformance investigations, audits, and inspection readiness, while serving as the primary quality contact for customers. The successful candidate will partner with engineering and operations on product development, process validation, manufacturing quality, and continuous improvement, while developing the quality team and advising executives on quality risks and business decisions. Candidates should have a bachelor’s degree in engineering, life sciences, or a related technical field, or equivalent experience, along with at least 10 years of progressive quality experience and five years in a leadership role. Experience in regulated manufacturing—particularly contract, custom, or job-shop manufacturing—is required. Strong knowledge of ISO 13485, FDA quality system requirements, and applicable medical device regulations is essential, as is expertise in CAPA, root cause analysis, auditing, inspections, calibration, and quality engineering. The role also calls for experience managing customer requirements and supporting customer audits, regulatory inspections, or certification audits, plus strong leadership and communication skills.