Sr. Quality System Data Specialist

Sr. Quality System Data Specialist

Date: Jul 28, 2026 Location: Wayne, NJ, US Company: Maquet Cardiovascular LLC Remote Work: 5 days at home (fully remote) Salary Range: The base salary is a minimum of $105,000 and a maximum of $130,000 plus 10% in annual bonus.

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 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. This role combines expertise in statistical analysis, data analytics, artificial intelligence (AI), and data integration to support businesses with pro-active signal detection, reducing patient risk. The Senior Specialist will work closely with Legal Manufacturers, Quality, Regulatory Affairs, Medical Safety, Service, Manufacturing, and Information Technology teams to develop methods and tools to identify trends, detect emerging signals, automate manual processes, and provide actionable insights that support data-driven decision making. This position is ideal for an analytical professional who enjoys solving complex problems, leveraging modern analytics and artificial intelligence (AI) tools, and helping business partners make informed decisions using data.

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.
• Data Analytics & Business Intelligence
• 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.
• Artificial Intelligence & Automation
• 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.
• Assist 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: Experience in one or more of the following areas is preferred: 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. Experience with one of more of the following applications: Power BI, Tableau, SQL, Python, R, Microsoft Fabric, Databricks, Snowflake, Azure analytics tools, Microsoft Copilot or similar AI platforms

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) and Service Business Areass (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 at Getinge

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 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. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.