Sr. Business Systems Analyst - Validation (CSA) Governance & Process Support

Arthrex; Naples (FL); Hybrid; USD 95,000 - 135,000; Full time

Benefits offered by this job

Medical Insurance

Life Insurance

401(k) Matching

Annual Bonus

Tuition Reimbursement

Paid Time Off

Job summary

Arthrex seeks a Sr. Business Systems Analyst - Validation to join the IT Quality team.

The role focuses on supporting Quality Systems, Regulatory Affairs, Product Development, and R&D with expertise in CSA validation, on-prem and cloud applications, and AI/ML considerations. The ideal candidate will drive process improvements, manage validation-related projects, and partner with business and IT stakeholders to deliver robust software solutions.

Qualifications

• Bachelor’s degree or equivalent required.
• 5+ years of Business Systems Analyst or related experience.
• Experience supporting validation, specifically software/system (CSA) processes preferred.
• Experience with reporting and analytics tools such as Power BI preferred.

Responsibilities

• Obtain a deep understanding of business processes to build high-quality requirements.
• Shape requirements by making recommendations and alternatives.
• Participate in Application Analysis, Configuration, Testing, Management, and Maintenance in an Enterprise environment.
• Support user acceptance testing and user training activities.
• Adhere to Quality System Procedures and Change Control.
• Lead or participate in delivery of projects.
• Provide Application End User support and resolve incidents.
• Coordinate application needs from back-end platforms through UI.
• Ensure stability, integration and integrity of production systems.

Skills

Communication

Requirements gathering

Stakeholder management

Quality systems

Education

Bachelor’s degree

Tools

Power BI

Job description

Sr. Business Systems Analyst - Validation (CSA) Governance & Process Support

Title: Sr. Business Systems Analyst - Validation (CSA) Governance & Process Support

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Sr. Business Systems Analyst - Validation (CSA) Governance & Process Support to join the IT team responsible for supporting Quality Systems, Regulatory Affairs, Product Development, and Research business teams. The IT Quality team governs and provides guidance for a variety of IT processes supporting the Arthrex Quality Management System (QMS), including Non-Product Software Validation (inclusive of both traditional programmatic software, and AI/Machine Learning models, functions, and features), IT Change Management, and other processes supporting validation and the software development lifecycle. Excellent communication, analytical, and technical project management skills are essential. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

*We would like for this position to sit with us at our Naples Florida Global Headquarters but we can be flexible on location for the right candidate.

Main Objective:

Responsible for facilitating process improvements engaging business and IT, as well as design and/or configure, analyze, implement, test, and maintain the organization’s on-premise and cloud computing applications.

Essential Duties and Responsibilities:

• Obtain a deep understanding of relevant business area(s) and business processes to be able to recommend solutions and build high-quality requirements.
• Shape business requirements by making recommendations and suggesting alternatives to proposed solutions.
• Participate in Application Analysis, Configuration, Testing, Management, and Maintenance in an Enterprise environment, including (where applicable):
  • Access administration and user onboarding.
  • Issue resolution, patching, and performance monitoring.
  • Reliability, backup, disaster recovery, and business continuity.
  • Monitor system logs for unusual activity and elevate or makes recommendations for resolution.
  • Participate in infrastructure projects to provide application specifications and requirements, as well as operational, run book, and capacity planning information.
• Support user acceptance testing and user training activities.
• Adhere to the Quality System Procedures and Change Control.
• Lead and/or participate in delivery of projects.
• Provide Application End User support.
• Respond, resolve, or elevate reported incidents.
• Under management direction, may participate as SME for audits.
• Responsible for coordinating application needs from back-end platforms through user interface.
• Ensure stability, integration, and integrity of production systems.
• Complete all QA Non-Conformance and Corrective Actions in a timely manner.
• Participate in assessment of application security and identity management requirements, where applicable.
• Create artifacts as appropriate, including business case documentation, scope documentation, detailed functional requirements, operational requirements, process flows, and manual and automated test cases.
• Understand technical options, limitations, costs, and risks.
• Communicate tradeoffs to business partners and work with them to shape requirements accordingly.
• Help resolve competing priorities between stakeholder groups by facilitating stakeholder discussions and elevate issues where appropriate.

Education and Experience:

• Bachelor’s degree or equivalent required.
• 5+ years of Business Systems Analyst or related experience required.
• Experience supporting validation, specifically software/system (CSA) processes preferred.
• Experience with reporting and analytics tools such as Power BI preferred.

Additional Duties and Responsibilities:

• Author and maintain Work Instructions, related process documentation, and technical documentation.
• Provide guidance and clarify process requirements for users planning and executing non-product-software validation processes.
• Facilitate training sessions where audiences arrive with differing levels of exposure and understanding of the topic/process being trained on.
• Benchmark current and future processes against industry best practices.
• Analyze business and internal IT process potentials for streamlining and improvements in efficiencies, leveraging traditional programmatic software and enabling/rationalizing the use of AI/ML models, functions, and features when applicable.
• Manage projects with cross functional teams and of global scope.

Specialized Skills:

• Ability to work comfortably at all levels within the organization up to the senior management level.
• Knowledge of Quality System Regulations, specifically in the context of (software) validation requirements preferred.
• Excellent communication (written and oral) and conflict management skills.
• General understanding of AI/ML concepts and topics preferred
• Experience developing and implementing AI/ML Agents and Models preferred.
• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Time Off
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.