Sr Quality Engineer - Post Market Data Analyst - jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr Quality Engineer - Post Market Data Analyst based in United States.

This role offers the opportunity to combine quality engineering expertise with advanced data analytics to improve product quality, regulatory compliance, and patient safety outcomes. You will transform complex post-market quality data into actionable insights that support better business and operational decisions. Working within a collaborative quality environment, you will partner with teams across regulatory, operations, manufacturing, and product functions. The position plays a key role in strengthening quality systems through analytics, reporting automation, and continuous improvement initiatives. You will contribute to data-driven strategies that enhance surveillance activities, risk management, and corrective action effectiveness. This remote opportunity is ideal for a detail-oriented quality professional who enjoys solving complex problems through data and innovation.

Accountabilities:

The Senior Quality Engineer – Post Market Data Analyst will be responsible for leveraging quality data, analytics, and engineering knowledge to support post-market surveillance, improve quality processes, and provide meaningful insights to stakeholders. The role requires strong collaboration skills and the ability to translate data findings into practical improvements.

• Develop, maintain, and automate complaint analytics dashboards, reports, and statistical trend analyses to monitor quality performance and identify emerging issues.
• Ensure the accuracy, integrity, and governance of complaint and quality system data through validation, reconciliation, audit trail management, and reporting improvements.
• Provide analytical support for complaint investigations, root cause analysis, risk management activities, and CAPA effectiveness evaluations.
• Collaborate with Quality Assurance, Regulatory Affairs, Product Development, Manufacturing, Engineering, and other cross-functional teams to identify trends and drive continuous improvement.
• Support internal and external audits, regulatory inspections, and compliance activities through accurate documentation, reporting, and quality system analysis.
• Improve business intelligence capabilities by identifying opportunities for enhanced reporting processes, automation, and data-driven decision-making.
• Contribute to maintaining effective quality management systems while supporting product reliability and customer safety objectives.

Requirements:

The ideal candidate brings a strong background in quality engineering, data analytics, and regulated environments, with the ability to combine technical expertise and business judgment to improve quality outcomes.