Quality Engineer

Medical Engineering Consultants (MEC); Minnesota; On-site; USD 96,000 - 131,000; Part time

Job summary

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.

Responsibilities

• 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.

Skills

Post-market surveillance

Statistical analysis

Data visualization

Power BI

Machine learning basics

Education

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

Tools

Power BI

Statistical modeling

Job description

Job 2829 - Quality Engineer - Contract located in Ramsey County, Minnesota

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.

Onsite

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.

Key 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.

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.

• Sponsorship is not available for this position

Check us out at www.medicalengineeringconsultants.com

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.