Quality System Manager

Key Responsibilities

• Lead the establishment, implementation, and maintenance of quality system requirements and business objectives for medical device software and Software as a Medical Device (SaMD) development projects in alignment with applicable procedures, regulations, and international standards.
• Develop, mentor, and lead a team of quality professionals to support compliance, business growth, product quality, and customer experience.
• Drive continuous improvement initiatives and organizational change efforts that enhance business agility, quality performance, and operational effectiveness, including through the CAPA system.
• Partner effectively across functions to identify and address quality risks, business opportunities, and process improvement priorities.
• Implement process and compliance improvements, leverage AI-enabled tools where appropriate to improve productivity and provide guidance or training on new and revise...