Senior Quality Assurance Manager

Senior Quality Manager | Orthopedic Medical Devices | Location: Gainesville, FL | Orthopedic Medical Devices A growing orthopedic medical device company is hiring a Manager of Quality Engineering to lead its Quality Engineering function and create an environment of organizational excellence that delivers results. Reporting into the wider Quality leadership team, you will provide direction to the Quality Engineering team while ensuring the Quality System is implemented and measured for effectiveness across product realization and compliance. This is a leadership hire with genuine ownership across design, manufacturing and regulatory compliance, suited to someone who can inspire teams while staying close to the technical detail. They need to understand and have hands on experience with the full QA life-cycle. What you will own: Compliance with FDA, ISO 13485, MDSAP and EU MDR, maintaining audit readiness and certification Leadership and development of the Quality Engineering team, aligning goals, performance and resources to business objectives Design controls, risk management, verification/validation and process validation, including GD&T, inspection and statistical requirements CAPA, root cause analysis and cross-functional resolution of quality issues Complaint and nonconformance investigation, containment, disposition and timely resolution, escalating risks as needed Quality metrics tracking and reporting to support Management Review and Quality Governance Acting as SME during internal and external audits and inspections What you must have: Bachelor's degree in a science discipline (Master's preferred) Minimum 7 years' experience, ideally in orthopedics or another medical device field Prior QA Engineering management experience in a medical device company Strong background in inspection specification development, statistical techniques, gage R&R and GD&T Audit experience with FDA and notified bodies Excellent verbal and written communication and leadership skills, with the ability to work across all organizational functions #J-18808-Ljbffr