Business Systems Analyst

Medical Engineering Consultants (MEC); Minnesota; Remoto; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Medical Engineering Consultants (MEC) is seeking a Business Systems Analyst for a remote contract role to design and maintain centralized dashboards and quality assessment tools. The candidate will enhance data validation, automate reporting, and support risk-based decision making in a FDA-regulated environment.

The role requires expert Excel, SQL, and Power BI skills, with 2-3 years in medical device quality processes and ISO 13485 familiarity. Sponsorship is not available for this position.

Competenze

• Expert-Level Microsoft Excel with advanced data modeling and dashboard skills.
• Advanced SQL for ETL, data extraction, and data quality controls.
• Power BI reporting with KPIs, trends, and automated dashboards for quality and compliance.
• Strong understanding of statistical analysis methods and SPC concepts.
• Knowledge of QMS processes (CAPA, complaints, nonconformance, risk).
• Experience in FDA-regulated medical devices (21 CFR Part 820) and ISO 13485.

Mansioni

• Design, develop, and maintain centralized reporting dashboards and automated exception reporting for quality monitoring.
• Build centralized quality assessment tracking and reporting systems with structured electronic tools.
• Develop statistical trending and analytics for remediation populations to identify risks and improvement opportunities.

Conoscenze

Excel

SQL

Power BI

Statistics

Quality Systems

Formazione

Bachelor's degree

Strumenti

Snowflake

Relational databases

Descrizione del lavoro

Job 2981 - Business Systems Analyst - Remote Contract

*Please note Sponsorship is not available for this position

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.

Remote

Core Responsibilities:

• Continuous Monitoring Control Engineering
• Design, develop, and maintain centralized reporting dashboards and automated exception reporting solutions that support ongoing quality monitoring activities. Implement systematic, risk-based data validation and business rule checks to identify potential errors, data inconsistencies, process deviations, and escalation-related exceptions requiring further assessment and follow-up.

Centralized Quality Assessment Solution:

• Develop, implement, and maintain a centralized quality assessment tracking and reporting system. Design structured electronic assessment tools that enable standardized data capture while supporting automated trending, statistical analysis, performance metrics, and dynamic dashboard visualization of assessment outcomes.

Remediation Population Analytics & Trending:

• Develop and maintain statistical trending models and analytical reporting for the remediation population. Analyze quality system data utilizing multidimensional filtering and segmentation techniques to identify emerging trends, process performance issues, potential compliance risks, and areas requiring corrective action or management attention.

Required Technical Skills & Qualifications:

• Expert-Level Microsoft Excel: Advanced proficiency in Excel including Tables, Power Query, Power Pivot, Pivot Tables/Charts, Slicers, dashboard development, and complex logical, lookup, and statistical formulas. Ability to analyze large quality datasets, automate data preparation, and develop executive-level metric reporting.
• Database & Query Management: Advanced experience extracting, transforming, and analyzing large datasets using SQL. Proficiency writing optimized queries in Snowflake and working with relational databases, data models, data governance principles, and data quality controls to support quality system monitoring and decision-making.
• Business Intelligence & Analytics: Advanced proficiency developing scalable reporting solutions and interactive dashboards in Power BI, including creation of calculated columns, KPIs, trend analyses, and automated reporting to support quality, compliance, and operational performance monitoring.
• Statistical Analysis & Data Interpretation: Strong understanding of statistical analysis methodologies including trend analysis, Pareto analysis, root cause analysis, process capability metrics, sampling principles, risk-based data analysis, and statistical process control (SPC). Ability to identify emerging signals, adverse trends, and quality system risks through quantitative analysis.
• Quality Systems Expertise: Strong working knowledge of core Quality Management System (QMS) processes including Complaint Handling, Similar Complaint Reviews (SCR), CAPA, Nonconformance Management, and Risk Management.
• Risk Management & Product Quality Analysis: Understanding of ISO 14971 risk management principles, including hazards, hazardous situations, harms, failure modes, occurrence rates, risk controls, and post-market surveillance activities.
• Medical Device Regulatory Knowledge: Minimum 2-3 years of experience in an FDA-regulated medical device environment with demonstrated knowledge of 21 CFR Part 820/QMSR, ISO 13485, complaint handling requirements, CAPA triggers, post-market surveillance.

Qualifications:

• Degree required. Someone with a stats or data analytics background

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.

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.