The OpportunityThe
Senior Quality Engineer - Data Analytics is responsible for transforming complaint and quality system data into actionable insights that drive product quality, patient safety, regulatory compliance, and continuous improvement. This full-time, permanent position combines quality engineering expertise with advanced analytics to support post-market surveillance activities, enable data-driven decision-making, and improve the effectiveness of IDT's Quality Management System. The role serves as a key business partner across Quality, Regulatory, and Operations organizations by providing meaningful trend analysis, business intelligence, and data governance support.
This position reports to the
Manager, QA Complaints and is part of the
Quality Assurance organization. This position is
fully remote within the United States.
In this role, you will have the opportunity to:- 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.
The essential requirements of the job include:- 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.
It would be a plus if you also possess previous experience in:- 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.
Travel, Motor Vehicle Record & Physical/Environment Requirements- Ability to travel up to 10% for team meetings, training, audits, inspections, or business-related activities.
- Ability to remain stationary and work at a computer for extended periods of time.
- Ability to communicate effectively through virtual collaboration tools, video conferencing platforms, and presentations.
- Ability to occasionally move materials and equipment associated with office and quality system activities.
Remote Work ArrangementAt IDT, we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for IDT can provide.
IDT, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job
The annual salary range OR the hourly range for this role is 66,000.00 - 115,500.00. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
