Post Market Complaint Trending

Job 2827 - Complaints 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.

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.

• 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.

• Build Quality into all aspects of…