Description:
Job Summary
Develops, maintains, and continuously improves post-market surveillance and complaint trending methodologies, tools, and processes to support product quality, patient safety, and regulatory compliance. Performs statistical analyses, signal evaluations, and complaint monitoring activities to identify emerging risks and product performance trends. Partners with Quality, Regulatory, Clinical, Engineering, and Risk Management stakeholders to provide data-driven insights that support decision-making across the product lifecycle.
Serves as a technical resource for post-market analytics, statistical process control, visualization development, and risk-based monitoring approaches. Supports the development and maintenance of analytical tools, dashboards, and automated solutions to enhance the effectiveness and efficiency of post-market surveillance.
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Key Responsibilities
1. Performs complaint monitoring, statistical trending, and signal evaluation activities to identify emerging product quality and patient safety concerns.
2 . Conducts signal assessments and presents findings, recommendations, and escalations to management review boards and cross-functional stakeholders.
3.Develops, maintains, and improves complaint monitors aligned with risk management documentation, product hazards, and surveillance requirements.
4. Executes ad hoc data analyses to support Quality, Regulatory, Clinical, Engineering, and business partner requests.
5 . Creates, maintains, and validates Power BI dashboards, visualizations, reports, and analytical tools.
6.Applies statistical methodologies and Statistical Process Control (SPC) techniques to evaluate product performance and identify meaningful trends.
7 . Collaborates with Risk Management teams to ensure surveillance activities remain aligned with product risks and evolving post-market requirements.
8.Supports continuous improvement initiatives through automation, data visualization, and process optimization efforts.
9.Investigates data anomalies and develops recommendations to improve data quality, monitoring effectiveness, and signal detection capabilities.
10. Communicates analytical findings to both technical and non-technical audiences through clear visualizations, presentations, and written summaries.
11 . Supports audit readiness and compliance with applicable quality system and regulatory requirements.
1 2.Contributes to the development of innovative analytical approaches, including machine learning techniques, predictive analytics, and advanced statistical methodologies where appropriate.
Quality Systems Duties and Responsibilities
Build Quality into all aspects of work by maintaining compliance with all quality system requirements, internal procedures, applicable regulations, and company standards.
Qualifications
Required Education: Bachelor's degree in one of the following disciplines:
•Statistics, Mathematics, Computer Science, Engineering, Data Science, Analytics or related technical field
Required Experience
•8+ years of experience with advanced analytics, tool development, statistical modeling, or post-market surveillance within a regulated industry.
• Understanding of Statistical Process Control (SPC) principles and methodologies.
• Experience performing statistical analyses and interpreting complex datasets.
• Knowledge of post-market surveillance and risk management principles.
• Experience supporting complaint trending, signal detection, or safety monitoring activities preferred.
• Proficiency with Python and/or R.
• Experience with SQL and relational databases.
• Experience developing Power BI dashboards and data visualization tools.
• Knowledge of machine learning methods and practical applications preferred.
• Experience with process automation and analytical tool development preferred.
• Familiarity with medical device, pharmaceutical, biotechnology, or other regulated industries preferred.