Business Systems Analyst, Quality
About The Position
Scanlan International, Inc., a medical device company specializing in surgical instruments, is seeking a Business Systems Analyst, Quality. This role supports the development, maintenance, and continuous improvement of Quality Management System (QMS) processes, applications, and data. The position acts as a liaison between Quality Assurance, Regulatory Affairs, Information Technology, and business stakeholders to identify process improvement opportunities, implement system enhancements, and ensure compliance with regulatory requirements. Responsibilities include business analysis, software validation support, reporting and metrics development, user training, and administration of quality-related systems and workflows. This is an individual contributor role based at the company's headquarters south of downtown St. Paul, with an on-site work environment expected Monday through Friday. The role reports to the Quality Improvement Manager.
Requirements
- 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.
- 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
Nice To Haves
- 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
- SQL or advanced reporting skills
- Power Platform development experience
- Project management experience
- Process improvement methodologies (Lean, Six Sigma, Agile)
Responsibilities
- Develop and maintain reports, dashboards, metrics, and data analyses to support management review, quality objectives, audit readiness, and operational decision-making.
- 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.
- Partner with business stakeholders to identify process improvement opportunities, document business requirements, perform workflow analysis, and support the 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 activities.
- Develop user guidance, training materials, and work instructions.
- Provide user support and perform any other duties as assigned.
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)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
