Quality Systems Analyst – QMS & Data Insights

Scanlan International, Inc.; Saint Paul (MN); On-site; USD 68,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

401(k) Plan with Company Match

Paid Time Off (Holidays, Vacation, ES

Training and Development Program

Job summary

Scanlan International, Inc. is a medical device company focused on high-quality surgical instruments.

We seek a Business Systems Analyst, Quality, to support the development, maintenance, and continuous improvement of QMS processes and data. This role liaises with Quality Assurance, Regulatory Affairs, IT, and business stakeholders to identify opportunities, implement enhancements, and ensure regulatory compliance.

Qualifications

• 3+ years of experience supporting business processes, quality systems, or regulated environments
• Experience gathering and documenting business requirements
• Experience participating in software implementation or system improvement projects
• Experience with data analysis and reporting
• Strong analytical and problem-solving skills
• Excellent written and verbal communication skills
• Experience with Microsoft 365 applications including Excel, Power BI, SharePoint, and Teams
• Ability to manage multiple priorities and projects
• Knowledge of process mapping and workflow analysis
• Ability to document procedures, requirements, and system changes
• Experience in medical device, pharmaceutical, biotech, or regulated manufacturing environments (preferred)
• Experience with ISO 13485, FDA QSR, MDR, or MDSAP (preferred)
• Experience supporting electronic Quality Management Systems (eQMS) (preferred)
• Experience with Jira, Document Locator, Power BI, Power Automate, DocuSign (preferred)
• SQL or advanced reporting skills (preferred)
• Process improvement methodologies (Lean, Six Sigma, Agile) (preferred)

Responsibilities

• Develop and maintain reports, dashboards, metrics, and data analyses that support management review, quality objectives, audit readiness, and operational decision-making
• Administer, support, and continuously improve quality management, workflow automation, electronic signature, reporting, database, ERP, and related business systems
• Collaborate with business stakeholders, vendors, and IT resources to ensure systems remain effective, compliant, and aligned with organizational needs
• Partner with business stakeholders to identify process improvement opportunities, document business requirements, perform workflow analysis, and support implementation of process changes
• Support computer software assurance (CSA), software validation, change control, risk assessments, and documentation activities to ensure compliance
• Participate in cross-functional projects involving quality systems, software applications, automation initiatives, and regulatory compliance improvements; coordinate testing, training, deployment, and post-implementation support
• Develop user guidance, training materials, and work instructions; provide user support and perform other duties as assigned

Skills

Analytical thinking

Problem solving

Written & verbal communication

Microsoft 365 (Excel, Power BI, Share

Education

Bachelor's degree

Tools

Jira

Document Locator

Power BI

Power Automate

DocuSign

Job description

Scanlan International, Inc. is a medical device company focused on high-quality surgical instruments.

We seek a Business Systems Analyst, Quality, to support the development, maintenance, and continuous improvement of QMS processes and data. This role liaises with Quality Assurance, Regulatory Affairs, IT, and business stakeholders to identify opportunities, implement enhancements, and ensure regulatory compliance.