Sr Quality Engineer - Post Market Data Analyst

Integrated DNA Technologies (IDT) is a company committed to innovation in life sciences and biotechnology. The Senior Quality Engineer – Data Analytics is responsible for transforming complaint and quality system data into actionable insights to support product quality, patient safety, and regulatory compliance, while collaborating with cross-functional teams to drive continuous improvement initiatives.

Responsibilities:

• Develop, maintain, and automate complaint analytics dashboards, reports, and statistical trend analyses to monitor quality performance, identify emerging signals, and support Quality Management Reviews, CAPA activities, and business decision-making
• Ensure the integrity, accuracy, and governance of complaint and quality system data through validation, reconciliation, audit trail management, and continuous improvement of reporting processes
• Provide data-driven support for complaint investigations, root cause analysis, risk management activities, and CAPA effectiveness evaluations to strengthen product quality and patient safety outcomes
• Collaborate with Quality Assurance, Regulatory Affairs, Scientific Application Support, Product Development, Manufacturing, Process Engineering, and other cross-functional stakeholders to identify trends and drive continuous improvement initiatives
• Support regulatory compliance, internal and external audits, and inspections through accurate reporting, analysis, documentation, and application of quality system requirements

Requirements:

• Bachelor's degree in Engineering, Data Science, Statistics, Computer Science, Quality, or a related technical discipline with 5+ years of relevant experience, OR a Master's degree in a related field with 3+ years of relevant experience
• Experience developing and maintaining business intelligence and reporting solutions using Power BI, Tableau, or similar data visualization platforms
• Proficiency in statistical analysis and data management tools, including SQL and Microsoft Excel, with experience using Minitab, JMP, R, or Python
• Working knowledge of ISO 13485, 21 CFR Part 820, 21 CFR Part 803, CAPA, complaint handling, risk management processes, and Quality Management System requirements
• Master's degree in Engineering, Data Science, Statistics, or a related technical field
• Medical device, in vitro diagnostics (IVD), biotechnology, or pharmaceutical industry experience
• ASQ Certified Quality Engineer (CQE) certification and/or experience supporting regulatory inspections and quality system audits