[Hiring] Senior Manager, Digital Quality Excellence @Getinge

Role Description

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.

Qualifications

• 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.

Requirements

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

Benefits

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement