Computer Software Assurance Supervisor (33969)

Job DetailsJob Location: Jacksonville, FL 32246Position Type: Full TimeEducation Level: 4 Year DegreeTravel Percentage: NegligibleJob Shift: DayWho We Are

At KLS Martin, we offer a unique opportunity to contribute to the success of a dynamic and thriving company whose products are used daily across the world to help surgical patients.  

The KLS Martin Group is a worldwide leader in creating surgical solutions for the craniomaxillofacial and cardiothoracic fields. Surgical innovation is our passion, and we are constantly working with surgeons to improve surgical care for their patients. Our product portfolio includes titanium and resorbable implants for reconstruction, innovative distraction devices to stimulate bone lengthening, over 4,000 surgical instruments, and other surgical products designed specifically for CMF and cardiothoracic surgeons.  

KLS Martin is an innovative leader in the treatment of CMF deformities and trauma cases. We use Individual Patient Solutions (IPS) by using our proprietary IPS products where CT scans are used to custom design implants that are created specifically for that individual patient.  This technology allows our surgeons to provide the best-in-class treatment for their patients. 

KLS Martin Guiding Principles 


Established, Privately Held Business Group – Responsive to customers, not shareholders. KLS Martin has manufactured medical products since 1896, and we have sold our products in the United States under the KLS name since 1993. We have always been, and always will be, privately owned.
Patient Focus – We design products with the patient in mind – CMF, Thoracic & Hand
Product to Table – Integrated planning, design, manufacturing and distribution process
Educational Partner – Our primary focus for support is on education
Inventory Alliance – Inventory management is critical to patient treatment/outcome
Surgical Innovation is Our Passion – More than just a tagline


What We Offer


We provide full-time employees with a competitive benefits package, including paid parental leave
In-house training and professional development opportunities
A culture of creativity and innovation by drawing on diverse perspectives and ideas to drive surgical innovation


Job Summary 

The CSA Supervisor facilitates and governs Computer Software Assurance (CSA) activities across regulatory and quality management systems in a regulated medical device environment.  As a key driver of process improvement, the CSA Supervisor identifies opportunities to streamline quality software validation practices, enhance system usability, and reduce compliance risk with respect to software applications. This role ensures software systems are implemented and maintained in compliance with FDA, ISO, and global regulatory requirements using risk-based CSA methodologies. Exercises discretion and independent judgement related, but not limited to, adverse event and the quality management system.

Essential Functions, Duties, and Responsibilities 

Project Leadership & Execution 


Facilitates and governs CSA validation activities.
Lead risk assessments, including review of URS/FRS, to determine appropriate CSA strategies for new and existing systems
Maintains validation documentation, and ensures regulatory compliance (test protocols, traceability matrices).
Ensure alignment with CSA principles, identify opportunities to simplify validation activities while maintaining compliance.


Cross-Functional Collaboration 


Partner with IT, Operations, and Manufacturing departments to ensure CSA activities support business and compliance needs.
Collaborate with stakeholders to optimize system implementation and change control processes
Facilitate stakeholder engagement and communication throughout the software lifecycle.
Support change control processes and system upgrades with appropriate CSA documentation
The scope of this role does not encompass business requirements elicitation, process design, IT project management, or system configuration. 


Continuous Improvement 


Identify opportunities to streamline CSA processes and improve system usability and compliance. 
Develop and deliver CSA training and guidance to internal teams. 
Track and report CSA project metrics and KPIs to leadership. 

QualificationsEducational and Experience Requirements 


Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related field. 
5+ years of experience in software validation, CSA, or CSV within the medical device or life sciences industry. 
Proven experience managing cross-functional projects in a regulated environment. 
Strong knowledge of FDA regulations, ISO standards (13485 preferred), and CSA methodologies. 
Excellent organizational, communication, and leadership skills. 


Knowledge, Skills, and Abilities 


PMP, or similar project Management certification, or Project Management experience 3+ years