Sr. Manager, Digital Quality Excellence; Remote
Cherry Hill, Camden County, New Jersey, 08034, USA
Listed on 2026-10-09
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IT/Tech
AI Business & Operations, Data Scientist, Data Analyst, Change Management
Date:
Sep 28, 2026
Location:
Wayne, NJ, US
Remote Work: 5 days at home (fully remote)
Salary Range: $178,000 - $215,000 + STIP 25%
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge 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 OverviewThe 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.
Job Responsibilities and Essential DutiesDigital Governance
- 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.
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 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,…
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