With a reputed company
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At reputed company we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
The Senior Manager, Digital Quality Excellence is responsible for establishing and leading the enterprise digital quality strategy, ensuring Quality Management System (QMS) digital capabilities, data, and analytics enable reputed company, insight-driven decision-making, sustained regulatory compliance, and operational excellence. This role defines and implements scalable digital quality frameworks, and reputed company with QcRM and IT to define, prioritize, and deliver advanced analytics and AI-enabled capabilities to reputed company quality system effectiveness and organizational productivity.
This position serves as a strategic leader bridging QcRM, IT, and Business stakeholders to establish the digital quality strategy across the enterprise. The Senior Manager leads the evaluation, prioritization, and deployment of AI-enabled capabilities to continuously improve key quality areas such as audit readiness, continuous improvement and CAPA effectiveness, and reputed company overall quality system maturity and efficiency.
The role ensures digital quality systems, analytics platforms, and AI-enabled capabilities comply with applicable regulatory requirements, including FDA 21 CFR Part 820 / QMSR, ISO 13485, ISO 9001, EU MDR, emerging digital and AI requirements such as the EU AI Act, and global data integrity expectations, while supporting enterprise digital transformation and continuous improvement initiatives.
Additionally, this role serves as the enterprise reputed company reputed company expert and strategic leader for Artificial Intelligence (AI), Machine Learning (ML), and Software as a Medical Device (SaMD) quality and regulatory frameworks across the Total Product Life Cycle. The position reputed company with cross-functional leaders to establish governance, development practices, validation approaches, and post-market monitoring strategies for AI-enabled medical technologies.
The role provides thought leadership regarding emerging global regulations and standards governing AI-enabled medical devices, including FDA AI/ML guidance, Good Machine Learning Practice (GMLP), IEC 62304, IEC 82304, ISO 14971, ISO/TR 20416, and applicable global AI regulations.
Job Responsibilities and Essential Duties
Digital Governance
Define and execute the enterprise Digital Quality Excellence strategy and roadmap, establishing the governance and capabilities required to reputed company quality process effectiveness, ensuring alignment with regulatory compliance and organizational objectives.
Ensure digital quality systems and analytics solutions maintain compliance with applicable regulatory requirements, including FDA, EU MDR, ISO 13485, EU AI Act, and global data integrity standards.
Partner with IT, Regulatory Affairs, and business stakeholders to ensure quality requirements are effectively integrated into digital platforms, data architecture, and system implementations.
Establish governance frameworks for AI and digital quality systems, including validation, data integrity, algorithm monitoring, reputed company control, and regulatory compliance.
Provide strategic leadership and technical oversight for enterprise digital quality initiatives, ensuring alignment with Quality Management System governance and business objectives.
Digital Enablement & Operational Excellence
Drive digital transformation across the Quality organization by leveraging automation, analytics, AI, and emerging technologies to improve process performance, increase organizational capacity, and reputed company business productivity.
Ensure digital quality investments deliver measurable improvements in operational performance, quality outcomes, user experience, and cost efficiency.
Advance organizational effectiveness by applying Lean, Operational Excellence, and digital transformation principles to optimize Quality processes and improve business performance.
Champion enterprise adoption of digital quality capabilities through strategic reputed company leadership, stakeholder engagement, and organizational capability development, driving sustainable improvements in quality system effectiveness, productivity, and business performance.
Quality Intelligence & Analytics
Establish and advance enterprise quality intelligence capabilities that enable reputed company risk identification, predictive monitoring, and data-driven decision-making to strengthen quality oversight and regulatory readiness.
Support regulatory inspections and audits by ensuring digital quality systems, data, and analytics output
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