Senior Quality Data Scientist – Post-Market Surveillance

Medical Engineering Consultants (MEC); Minnesota; Sur place; USD 96 000 - 131 000; Temps partiel

Résumé du poste

Medical Engineering Consultants (MEC) is seeking a Quality Engineer on a contract basis in Ramsey County, Minnesota. The role focuses on post-market surveillance, complaint trending, and data-driven quality improvements in a regulated environment.

You will develop analytics, create dashboards in Power BI, and collaborate with Quality, Regulatory, Clinical, Engineering, and Risk teams to drive patient safety and regulatory compliance across the product lifecycle.

Qualifications

• Bachelor's degree in Statistics, Mathematics, CS, Engineering, Data Science or analytics.
• 8+ years of experience with advanced analytics, tool development, statistical modeling, or post-market surveillance in a regulated industry.

Responsabilités

• Performs complaint monitoring, statistical trending, and signal evaluation activities to identify quality and patient safety concerns.
• Conducts signal assessments and presents findings to management review boards and cross-functional stakeholders.
• Develops, maintains, and improves complaint monitors aligned with risk management documentation and surveillance requirements.
• Executes ad hoc data analyses to support Quality, Regulatory, Clinical, Engineering, and business partner requests.
• Creates, maintains, and validates Power BI dashboards, visualizations, reports, and analytical tools.
• Applies statistical methodologies and SPC techniques to evaluate product performance and identify meaningful trends.
• Collaborates with Risk Management teams to ensure surveillance activities align with product risks.
• Supports continuous improvement through automation, data visualization, and process optimization.
• Investigates data anomalies and develops recommendations to improve data quality, monitoring effectiveness, and signal detection capabilities.
• Communicates analytical findings to both technical and non-technical audiences via clear visualizations, presentations, and summaries.
• Supports audit readiness and compliance with applicable quality system and regulatory requirements.
• Contributes to innovative analytical approaches, including machine learning techniques when appropriate.

Connaissances

Post-market surveillance

Statistical analysis

Data visualization

Power BI

Machine learning basics

Formation

Bachelor's degree in Statistics

Bachelor's degree in Mathematics

Bachelor's degree in Computer Science

Bachelor's degree in Engineering

Bachelor's degree in Data Science

Bachelor's degree in Analytics or related field

Outils

Power BI

Statistical modeling

Description du poste

Medical Engineering Consultants (MEC) is seeking a Quality Engineer on a contract basis in Ramsey County, Minnesota. The role focuses on post-market surveillance, complaint trending, and data-driven quality improvements in a regulated environment.

You will develop analytics, create dashboards in Power BI, and collaborate with Quality, Regulatory, Clinical, Engineering, and Risk teams to drive patient safety and regulatory compliance across the product lifecycle.