Quality Engineer

Medical Engineering Consultants (MEC); Arden Hills (MN); On-site; USD 75,000 - 105,000; Full time

Job summary

Medical Engineering Consultants (MEC) seeks a Quality Engineer on a contract basis near Minneapolis, Minnesota. The role focuses on post‑market surveillance, data analytics, and regulatory compliance to improve product quality and patient safety.

You will develop and maintain analytical tools and dashboards (Power BI), perform SPC analyses, and collaborate with cross‑functional teams to support the product lifecycle.

Applicants must be authorized to work in the U.S.; sponsorship is not available.

Qualifications

• 0–3 years of experience in data analytics, statistical analysis, quality engineering, post‑market surveillance, or related field.
• Background in statistics, mathematics, or data science.
• Experience with post‑market surveillance and regulatory compliance is a plus.

Responsibilities

• Performs complaint monitoring, statistical trending, and signal evaluation to identify product quality and safety concerns.
• Conducts signal assessments and presents findings to cross‑functional stakeholders.
• Develops and maintains complaint monitors aligned with risk management documentation.
• Executes ad hoc data analyses to support Quality, Regulatory, Clinical, Engineering, and business partners.
• 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 stay aligned with product risks.
• Supports continuous improvement through automation and data visualization.
• Investigates data anomalies and recommends improvements to data quality.

Skills

Data analytics

Statistical analysis

Quality engineering

Post-market surveillance

Education

Statistics

Mathematics

Computer Science

Engineering

Data Science

Analytics or related technical field

Tools

Power BI

Job description

Job 2830 - Quality Engineer - Contract located near Minneapolis, 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.

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 post‑market surveillance effectiveness and efficiency.

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:

• Statistics
• Mathematics
• Computer Science
• Engineering
• Data Science
• Analytics or related technical field

Required Experience

• Associate / Junior Level
• 0-3 years of experience in data analytics, statistical analysis, quality engineering, post‑market surveillance, or related field.

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

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.