Getinge

Quality Systems Data Analyst (Wayne, NJ)

Getinge

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $80,000 - $90,000 per year

Job Level

Junior

Tech Stack

PythonSQLTableau

About the role

  • 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.

Requirements

  • 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