The Quality Systems Business Analyst Intern plays a key role in optimizing processes and driving digital transformation within the ISO 13485 Quality Management System (QMS). This position gathers and documents process requirements, conducts monthly and quarterly QMS data analyses, and supports initiatives that improve compliance, efficiency, and overall operational performance.
Position Responsibilities / Essential Functions:
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| Requirements Gathering & Process Analysis (Primary Focus) - Assist with reviewing current quality processes (such as CAPA, training, document control, and supplier controls).
- Help organize meetings with process owners to learn about workflows and identify basic improvement ideas.
- Support the documentation of project requirements and help prepare simple workflow diagrams.
- Learn about regulatory standards (ISO 13485, 21 CFR 820, MDSAP) and assist with basic compliance checks.
- Help coordinate information sharing between teams.
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| QMS Data Analysis & Management Review - Collect and organize quality data from spreadsheets and databases.
- Help update the monthly Quality Metrics Dashboard with basic data entries.
- Assist in identifying trends or issues in the data and report findings to the team.
- Support the preparation of management review materials, such as charts and summaries.
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| Continuous Improvement & Project Support - Work with the Quality Improvement Manager to keep project schedules up to date.
- Suggest improvement ideas based on observations and data.
- Assist with basic investigations and help document findings.
- Track progress of ongoing projects and report updates.
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| Verification, Validation & Documentation Support - Participate in team meetings to learn about validation requirements.
- Help gather and organize data for validation activities.
- Ensure documentation is complete and organized.
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| Training & Organizational Change Management - Support the rollout of new workflows by helping prepare training materials.
- Assist with onboarding activities for new processes or tools.
- Help monitor adoption and gather feedback from users
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QUALIFICATIONS:
Required Qualifications: |
Education: - Pursuing a Bachelor’s degree in engineering, science, quality, business analytics, or related field.
Experience: - Demonstrated experience in:
- Business/process analysis
- Requirements gathering
- Data analysis (Excel, dashboards, metrics trending)
Skills: - Proficiency with Excel (VLOOKUP/XLOOKUP, pivot tables, charts, basic statistical functions).
- Ability to translate data into actionable insights and communicate trends clearly.
- Strong writing skills, especially in documentation and requirements definition.
Preferred Qualifications: - Experience with QMS software platforms or document management systems.
- Familiarity with Power BI, SQL, or advanced Excel/automation tools.
- Lean, Six Sigma, or process improvement training.
- Experience collaborating with software development or IT teams.
- Understanding of design controls, risk management, and validation documentation.
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