Note: The job is a remote job and is open to candidates in USA. 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
Skills
- 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
Benefits
- Fully remote within the United States
- Work remotely from your home
- Paid time off
- Medical/dental/vision insurance
- 401(k) to eligible employees
- This job is also eligible for bonus/incentive pay
Company Overview
Company H1B Sponsorship