Quality Systems Data Analyst (Wayne, NJ)

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 Overview

We are seeking a results-driven and detail-oriented Data Analyst to support our Quality organization. This hybrid role plays a key part in driving data-informed decision-making and leading strategic quality initiatives across the organization. The ideal candidate will analyze quality data trends, lead process improvement projects, and ensure compliance with applicable medical device regulations and standards.

The position supports the Cardiac Surgery business and is a hybrid role with a minimum of 3 days onsite at the Wayne, NJ headquarters.

Job Responsibilities and Essential Duties:

Data Analytics and Compliance Documentation:

• Collect, clean, analyze, and visualize quality-related data (e.g., CAPA (Corrective Action Preventative Action), complaints, non-conformances, audits). Specifically pull data for Complaints and CAPAs from the OneTrack system and NCMRs (Nonconforming Materials Report) from CATSweb.
• Develop dashboards and KPIs to monitor quality system health and drive continuous improvement.
• Perform root cause analysis using statistical tools and techniques (e.g., Pareto, trend analysis, regression).
• Provide insights and data-driven recommendations to leadership and cross-functional teams.
• Ensure alignment of data analytics and quality projects with ISO 13485, FDA QSR (21 CFR Part 820), and other relevant regulations.
• Support audits and inspections by preparing data summaries and project documentation.
• Contribute to the development and maintenance of standard operating procedures (SOPs), work instructions, and training materials.

Project Management /Coordination:

• Lead and coordinate quality system improvement projects from initiation to completion.
• Define project scope, objectives, timelines, and deliverables in collaboration with stakeholders.
• Track and report project progress, manage risks, and drive accountability for on-time delivery.
• Facilitate cross-functional meetings, document decisions, and follow up on action items.

Required Knowledge, Skills, and Abilities

• Bachelor's Degree in Engineering, Data Analytics, or related field or a combination of equivalent experience and education
• 1 to 3 years of experience in quality, data analysis, or project management within the medical device industry
• Experience with quality systems such as CAPA, audit management, change control, and document control
• Proficient in data analysis and visualization tools (Excel, Power BI, Tableau, Minitab, or similar)
• Experience with project management tools (MS Project, Smartsheet, Jira, etc.)
• Familiarity with SQL, Python, or other data scripting languages
• Must be comfortable handling sensitive quality and compliance data
• Strong communication, presentation, and organizational skills
• Proficient using Microsoft office suite

The base salary for this position is a minimum of 80,000 and a maximum of 90,000 plus 8% STIP

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.

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