Business Systems Analyst, Quality

Scanlan International, Inc., is a medical device company specializing in the highest-quality surgical instruments. Now in our fourth generation, the Scanlan family continues its dedication to providing the best surgical instrumentation available anywhere in the world.

About the role

The Business Systems Analyst, Quality supports the development, maintenance, and continuous improvement of Quality Management System (QMS) processes, applications, and data. This position serves as a liaison between Quality Assurance, Regulatory Affairs, Information Technology, and business stakeholders to identify opportunities for process improvement, implement system enhancements, and support compliance with applicable regulatory requirements. The role is responsible for business analysis, software validation support, reporting and metrics development, user training, and administration of quality-related systems and workflows. This position is based out of our headquarters office, south of downtown St. Paul, and follows an on-site work environment Monday through Friday. This is an individual contributor role reporting to the Quality Improvement Manager.

Responsibilities

• Reporting & Data Analysis
  • Develop and maintain reports, dashboards, metrics, and data analyses that support management review, quality objectives, audit readiness, and operational decision-making.
• Systems Administration
  • Administer, support, and continuously improve business applications and enterprise systems, including quality management, workflow automation, electronic signature, reporting, database, ERP, and related business systems.
  • Configure system settings and workflows, troubleshoot technical and user issues, maintain system data and documentation, coordinate upgrades and enhancements, and provide ongoing support to system users.
  • Collaborate with business stakeholders, vendors, and IT resources to ensure systems remain effective, compliant, and aligned with organizational needs.
• Business Analysis & Process Improvement
  • Partner with business stakeholders to identify process improvement opportunities, document business requirements, perform workflow analysis, and support implementation of process changes that improve compliance, efficiency, and effectiveness.
• System Validation & Compliance
  • Support computer software assurance (CSA), software validation, change control, risk assessments, and documentation activities to ensure compliance.
• Project Support & Implementation
  • Participate in cross-functional projects involving quality systems, software applications, automation initiatives, and regulatory compliance improvements.
  • Coordinate testing, training, deployment, and post-implementation support activities.
• Training & General Support
  • Develop user guidance, training materials, and work instructions.
  • Provide user support and perform any other duties as assigned.

Requirements

• Education:
  • Bachelor's degree in Business, Data Analytics, Information Systems, Quality, Engineering, Life Sciences, or a related field; or an equivalent combination of education and relevant experience.
• Experience:
  • 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
• Skills:
  • 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

Preferred Qualifications

• Experience:
  • Experience in a medical device, pharmaceutical, biotech, or regulated manufacturing environment
  • Experience with ISO 13485, FDA Quality System Regulation, MDR, or MDSAP requirements
  • Experience supporting electronic Quality Management Systems (eQMS)
  • Experience with Jira, Document Locator, Power BI, Power Automate, DocuSign, or similar platforms
  • Experience supporting software validation or Computer Software Assurance (CSA) activities
• Skills:
  • SQL or advanced reporting skills
  • Power Platform development experience
  • Project management experience
  • Process improvement methodologies (Lean, Six Sigma, Agile)

Pay

The salary range for this position is $68,400 – $109,500. Starting pay will typically fall between these values and is determined based on factors such as relevant experience, skills, and internal equity. Offers near the higher end of the range are reserved for candidates with exceptional qualifications.

Benefits

• Medical, Dental, and Vision Insurance
• Group Life Insurance
• Short-Term Disability Insurance
• Long-Term Disability Insurance
• 401(k) Plan with Company Match
• Workers' Compensation
• Employee Assistance Program (EAP)
• Regular Part-Time Benefit Eligibility
• Training and Development Program
• Tuition Assistance Program
• Paid Time Off, including holidays, floating holidays, vacation, earned sick and safe time (ESST)