Quality Systems Analytics Engineer

About the role

The Quality Systems Analytics Engineer performs data analytics across key quality management system processes to drive strategy for Quality and Regulatory functions and support the overall growth of the business. This role leads and influences the organization by using quality-driven metrics and data to enhance patient safety, improve customer experience, and strengthen regulatory compliance in a global market. The engineer designs and maintains analytical solutions, transforms complex data into actionable insights, and supports continuous process improvement initiatives.

Responsibilities

• Rebuild and redesign the quality engineering analytics framework to better support Quality and Regulatory strategies.
• Oversee, update, and maintain a critical Power BI report, ensuring it evolves beyond a simple complaint report into a comprehensive quality analytics solution.
• Design and implement new Power BI solutions, including dashboards, charts, and reports that provide meaningful insights for stakeholders.
• Develop and implement workflow processes to automate and guide how Power BI reports function, including data refreshes and report distribution.
• Collaborate with team members who currently perform work in Excel to identify opportunities for automation and streamline their tasks.
• Automate Excel charts, formulas, and related processes to improve efficiency and reduce manual effort.
• Connect to multiple data sources, such as Excel, Grand Avenue, ERP systems, calibration programs, and other linked platforms, to extract and integrate data for analysis.
• Diagnose data source and connectivity issues, perform data cleaning, and ensure the accuracy, completeness, and reliability of data used for reporting.
• Visualize data using appropriate tools and techniques, interpret trends and patterns, and draw clear conclusions that support decision-making.
• Analyze data to identify errors, recommend corrective actions, and support improvements in quality and regulatory processes.
• Support process improvement projects by providing data-driven insights and tracking the impact of implemented changes.
• Work closely with the engineering team to support CAPA (Corrective and Preventive Action) projects through robust data analysis and reporting.
• Stay informed about AI and technological advancements relevant to data analytics and quality systems and apply new capabilities where appropriate.
• Ensure that all analytics and reporting activities align with FDA and ISO guidelines and support regulatory compliance.

Requirements

• Bachelor’s degree in Engineering or a related field.
• Proficiency with Power BI, including the ability to turn data into dashboards, charts, and reports.
• Working knowledge of SQL to extract and manipulate data from databases.
• Experience analyzing data to draw conclusions, make recommendations, and correct errors.
• Experience working within FDA and ISO guidelines.
• Demonstrated involvement in process improvement initiatives.
• Openness to learn and adopt AI and emerging technology relevant to analytics and quality systems.

Skills

• Experience using SQL to retrieve data from databases for reporting and analysis.
• Python experience for analyzing, automating, and manipulating data.
• Experience with Data Breaks or similar data platform tools.
• Familiarity with quality systems tools and environments such as ERP systems, calibration programs, and other integrated platforms.
• Understanding of regulatory environments and quality management systems, including FDA and ISO frameworks.
• Strong communication skills to collaborate effectively with engineering and cross-functional teams.
• Ability to design and automate Excel-based reports, charts, and formulas.

Work Environment

This role is based in an office environment and typically follows an 8:00 a.m. to 5:00 p.m. schedule, with flexibility on start time as needed. The position involves regular use of analytics and data visualization tools such as Power BI, SQL, Excel, and other data platforms integrated with systems like ERP and calibration programs. The work focuses on collaborating with engineering and other functional teams in a professional setting to support quality, regulatory, and process improvement initiatives.

Schedule

This is a Contract to Hire position based in Grand Rapids, MI, with a typical schedule of 8:00 a.m. to 5:00 p.m.

Pay

The pay range for this position is $38.46 - $48.07 per hour.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may include:

• Medical, dental, and vision insurance
• Critical Illness, Accident, and Hospital coverage
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)