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...
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