Director Quality Operations

Director, Quality OperationsPosition SummaryThe Director of Quality Operations will lead quality strategy and operational execution for an exciting fast-paced, high-growth medical device company. This role is responsible for ensuring the consistent delivery of safe, compliant, and high-quality products while driving operational excellence across quality systems, manufacturing quality, supplier quality, and regulatory compliance activities.The successful candidate will thrive in a dynamic environment, partnering cross-functionally to scale quality operations, support business growth, and maintain compliance with FDA QSR, ISO 13485, MDR, and other global regulations.Key ResponsibilitiesLead and continuously improve the Quality Management System (QMS) to ensure global regulatory compliance. Oversee manufacturing quality, supplier quality, CAPA, audits, nonconformance management, and inspection readiness activities. Serve as the quality lead during FDA inspections, notified body audits, and customer audits. Drive a culture of continuous improvement using Lean and Six Sigma methodologies. Partner closely with Operations, Supply Chain, Regulatory Affairs, and R&D to support rapid growth and operational scalability. Establish and monitor KPIs to improve product quality, operational efficiency, and compliance performance. Build, mentor, and develop high-performing quality teams in a fast-moving environment. QualificationsBachelor’s degree in Engineering, Life Sciences, Quality, Operations, or related field. 10+ years of quality experience within medical devices or other highly regulated industries. 5+ years of leadership experience in fast-paced manufacturing or operational environments. Strong working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDR, and global quality regulations. Proven experience leading audits, quality improvement initiatives, and supplier quality programs. Strong leadership, communication, and problem-solving skills with the ability to operate effectively in a high-growth environment.