Quality Engineer II

Redbock - an NES Fircroft company; Minneapolis (MN); On-site; USD 75,000 - 110,000; Full time

Job summary

Redbock - an NES Fircroft company in Minneapolis, MN, seeks a data analytics professional to support post-market surveillance for a 12-month on-site contract. You will analyze complaints, perform trending, and develop tools to improve product safety and regulatory compliance.

You will collaborate with Quality, Regulatory, Clinical, and Engineering teams, build dashboards in Power BI, and apply SPC methods to identify meaningful trends.

Qualifications

• Bachelor's degree in statistics, mathematics, computer science, or data science.
• 2-4 years of experience with statistical analysis and post-market surveillance.
• Experience with Statistical Process Control (SPC) principles.
• 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.
• Familiarity with regulated industries preferred.

Responsibilities

• Performs complaint monitoring, statistical trending, and signal evaluation to identify quality and patient safety concerns.
• Conducts signal assessments and presents findings to stakeholders and review boards.
• Develops, maintains, and improves complaint monitors aligned with risk management and surveillance requirements.
• Executes ad hoc data analyses for cross-functional teams.
• Creates, maintains, and validates Power BI dashboards, visualizations, and reports.
• Applies Statistical Process Control (SPC) techniques to evaluate product performance and trends.
• Collaborates with Risk Management to align surveillance with product risks.
• Supports automation and analytics tool development to improve efficiency.
• Investigates data anomalies and proposes data quality improvements.
• Communicates analytical findings clearly to technical and non-technical audiences.

Skills

Python

R

SQL

Power BI

Data visualization

Statistics

Machine learning

Data analysis

Education

Bachelor's degree in Statistics

Bachelor's degree in Mathematics

Bachelor's degree in Computer Science

Bachelor's degree in Data Science

Tools

Power BI

SQL databases

Python tooling

Excel

Job description

12 Month Contract // On-site in Minneapolis, MN

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 post-market surveillance effectiveness and efficiency.

Duties/Responsibilities:

• Performs complaint monitoring, statistical trending, and signal evaluation activities to identify emerging product quality and patient safety concerns.
• Conducts signal assessments and presents findings, recommendations, and escalations to management review boards and cross-functional stakeholders.
• Develops, maintains, and improves complaint monitors aligned with risk management documentation, product hazards, 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 Statistical Process Control (\"SPC\") techniques to evaluate product performance and identify meaningful trends.
• Collaborates with Risk Management teams to ensure surveillance activities remain aligned with product risks and evolving post-market requirements.
• Supports continuous improvement initiatives through automation, data visualization, and process optimization efforts.
• 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 through clear visualizations, presentations, and written summaries.
• Supports audit readiness and compliance with applicable quality system and regulatory requirements.
• Contributes to the development of innovative analytical approaches, including machine learning techniques, predictive analytics, and advanced statistical methodologies where appropriate.

Qualifications/Requirements:

• Bachelor's degree in one of the following disciplines:
• Statistics
• Mathematics
• Computer Science
• Data Science
• 2-4 years of experience in statistical analysis, post-market surveillance, quality engineering, or data science.
• 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.