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

About the Position

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. We are actively seeking a Sr. Business Systems Analyst – Validation (CSA) Governance & Process Support to join our 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.

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 escalate 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 escalate 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 escalate issues where appropriate.

Requirements

• 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.

Nice to Have

• General understanding of AI/ML concepts and topics preferred.
• Experience developing and implementing AI/ML Agents and Models preferred.

We Offer

• 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 Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

About the Company

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. We are focused on Helping Surgeons Treat Their Patients Better™.

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.