We are seeking an experienced Quality Systems Manager who will be responsible for developing, executing, and maintaining a quality system and quality control processes in full compliance with FDA, ISO and other global regulatory requirements. Functional activities include: design review, record review, document control, change control, BOM/parts change management, calibration& preventive maintenance management, training management, lot release, manufacturing support and non-conformance / CAPA / complaint resolution. The Quality Systems Manager is responsible for ensuring all departments following the company’s quality procedures, and will be required to utilize process improvement methodologies and risk-based principles to identify opportunities, develop and execute improvement plans, and monitor activities to ensure a proactive state of compliance. This position reports to the CEO and works closely with our research and development (R&D) team. An ambitious candidate with a track record of successfully implementing and managing quality operations would thrive in this role.