Sr. Quality System Data Specialist

Job Overview

The Sr. Quality Data & Analytics Specialist is responsible for transforming data into meaningful insights that support product quality, patient safety, regulatory compliance, and operational excellence within global Getinge.

Job Responsibilities And Essential Duties

• Statistical Analysis & Trending
• Act as a Subject Matter Expert in Statistical methods, supporting legal manufacturers with selection of appropriate statistical methodologies (when needed) to evaluate product performance and quality indicators.
• Develop and implement dashboards, scorecards, and visualizations supporting analyses to identify trends, patterns, anomalies, and emerging signals within quality and post-market data.
• Continuously improve insights of dashboards, scorecards and visualizations utilizing data from multiple business systems and tools and other sources.
• Design output to support action determination.
• Present complex analytical findings in a manner understandable to both technical and non-technical audiences.
• Support management reviews and quality performance reporting activities.
• Data Analytics & Business Intelligence
• Identify opportunities to leverage AI and automation to improve the efficiency and effectiveness of signal detection, including trend analysis, data extraction, process automation, and knowledge management.
• Evaluate emerging AI technologies and recommend practical business applications.
• Support implementation, testing, validation, and monitoring of AI-enabled solutions.
• Follow and help establish best practices for responsible and effective use of AI within regulated business processes.
• Data Management & Integration
• Work with data from multiple sources, including Complaint handling systems, CAPA systems, ERP systems, Service databases, Manufacturing systems (e.g. NCR), Customer feedback systems.
• Identify opportunities to improve data quality, accessibility, and usability.
• Collaborate with IT and stakeholders to improve data connectivity and analytics capabilities.
• Aid in developing data models and reporting structures that support business needs.
• Cross-Functional Collaboration
• Partner with Legal Manufacturers and functional stakeholders to understand business questions and analytics needs.
• Support quality and regulatory initiatives through data-driven analyses.
• Participate in continuous improvement projects focused on quality system effectiveness.
• Act as a trusted resource for analytics, statistical interpretation, and AI-related opportunities.
• Provide training and guidance to business partners on data interpretation and dashboard utilization.

Required Knowledge, Skills And Abilities

• Bachelor’s or Master’s Degree in a relevant field (e.g., statistics, data science, biostatistics, mathematics, or equivalent combination of education and experience is required).
• A minimum of 5 years relevant experience in the following fields: data analytics, data science, medical device quality, healthcare analytics, statistical techniques.
• Solid knowledge and application of Descriptive statistics, Statistical trend analysis, Hypothesis testing, Risk-based monitoring, Data visualization techniques.
• Ability to interpret complex datasets, support identification of meaningful trends and signals, & communicate statistics concepts clearly.
• Problem solver & critical thinker with attention to detail.
• Understanding of Generative AI, Large Language Models (LLMs), Machine Learning fundamentals, Natural Language Processing (NLP), Predictive analytics, Data automation tools, Responsible AI principles.
• Ability to identify practical applications of AI that improve processes and efficiency.
• Curiosity for emerging technologies and analytical methods, continuous improvement mindset.
• Ability to communicate effectively.
• Demonstrate ability to work collaboratively in a cross-functional environment.

Internal and External Contacts/Relationships

• Getinge Sr Leadership and Executive Team
• Global Process Caretakers
• Functional Global leads in BAs (Acute Care Therapies, Surgical Workplaces, Life Science)
• Service Business Asses (OpS, SSU)
• Local Quality Managers (LQMs)/Management Representatives (MRs)
• External Agencies including FDA, Notified Bodies, and other regulatory agencies
• Information Technologies, including Digital & Global Technology Services

About Us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

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

Reasonable Accommodations

At Getinge, we offer a comprehensive benefits package, which includes: 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

Equal Opportunity Employer

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.