Sr. Manager, Digital Quality Excellence (Remote, US)

Getinge•Sacramento, CA

6d•$178,000 - $215,000•Remote

About The Position

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 proactive, insight-driven decision-making, sustained regulatory compliance, and operational excellence. This role defines and implements scalable digital quality frameworks, and partners with QcRM and IT to define, prioritize, and deliver advanced analytics and AI-enabled capabilities to enhance 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 enhance 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 subject matter 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 partners 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.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Computer Science, Data Science, or related technical discipline required. Advanced degree preferred.
Minimum of 8 years of experience in Quality Systems, Quality Engineering, Digital Quality, Analytics, or related roles within a regulated industry such as medical devices, pharmaceuticals, or biotechnology.
Minimum of 5 years of leadership experience managing teams and enterprise-level initiatives.
Strong working knowledge of global Quality Management System requirements, including FDA 21 CFR Part 820 / QMSR, ISO 13485, ISO 9001, and EU MDR.
Experience implementing digital quality systems, analytics platforms, dashboards, or enterprise data solutions.
Experience leading cross-functional initiatives involving Quality, IT, Regulatory Affairs, and business stakeholders.
Experience with AI, machine learning, advanced analytics, or digital health technologies within a regulated environment.
Strong expertise in Quality Management Systems, regulatory compliance, and quality processes including complaints, CAPA, audits, and management review.
Demonstrated experience developing enterprise analytics, dashboards, and data-driven performance management frameworks.
Understanding of digital technologies, data governance, system integrations, and enterprise data architecture.
Ability to translate emerging technological capabilities into compliant, scalable business solutions while effectively managing operational and regulatory risk.
Demonstrated hands-on leadership implementing and scaling digital, AI, and data-driven solutions within regulated Quality environments.
Experience applying Computer System Validation (CSV) and/or Computer Software Assurance (CSA) principles in regulated environments.
Understanding of machine learning model development lifecycles.
Knowledge of training, testing, validation, and monitoring of AI models.
Understanding of algorithm drift, bias mitigation, explainability, and model governance.
Ability to evaluate AI development methodologies and quality controls.
Ability to translate evolving AI regulations into actionable business and product development practices.
Experience developing enterprise governance frameworks and operating models.
Strong leadership, strategic thinking, and organizational skills.
Ability to influence senior leadership and drive enterprise-wide initiatives.
Excellent written and verbal communication skills.
Strong problem-solving and decision-making capabilities.
Ability to manage multiple priorities in a complex, global environment.
Ability to lead change and drive adoption of new digital capabilities.

Nice To Haves

Knowledge of AI, machine learning, or advanced analytics applications within regulated environments preferred.
Proficiency in analytics and reporting tools such as Power BI, Tableau, or similar platforms preferred.
RAC, ASQ CSQE, or software quality certifications preferred.

Responsibilities

Define and execute the enterprise Digital Quality Excellence strategy and roadmap, establishing the governance and capabilities required to enhance 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, change 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.
Drive digital transformation across the Quality organization by leveraging automation, analytics, AI, and emerging technologies to improve process performance, increase organizational capacity, and enhance 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 change leadership, stakeholder engagement, and organizational capability development, driving sustainable improvements in quality system effectiveness, productivity, and business performance.
Establish and advance enterprise quality intelligence capabilities that enable proactive 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 outputs are accurate, reliable, and audit-ready.
Develop enterprise governance frameworks for AI across product development, quality systems, regulatory compliance, and post-market activities.
Establish and maintain the enterprise strategy for AI-enabled medical devices and Software as a Medical Device (SaMD).
Serve as the senior advisor to executive leadership on emerging AI technologies, risks, opportunities, and regulatory developments.
Enable QcRM partnership with product development teams to ensure AI-enabled products are designed and developed in compliance with applicable regulations and standards.
Lead interpretation and deployment of global AI and SaMD regulations and standards.
Assess impact of emerging regulations and standards on product development and quality systems.
Perform other duties as assigned.