Computer Software Assurance Supervisor
KLS MARTIN LP
- 2.9 Jacksonville, FL Job Details Full-time 7 hours ago Benefits Paid parental leave Parental leave Qualifications Computer operation ISO standards Regulatory compliance Bachelor's degree Task prioritization Cross-functional collaboration Project leadership Cross-functional team management FDA regulations Full Job Description
- This role is considered locally remote, interested applicants must reside within 50 miles of our office in Jacksonville, FL.
- Who 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. Educational 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 Experience with Agile, or hybrid SDLC methodologies Strong interpersonal skills with the ability to effectively communicate (written and verbal) at all levels internally as well as externally Utmost respect for confidentiality Extreme attention-to-detail Excellent organizational skills Ability to properly manage time and multiple priorities Strong ability for problem solving, adaptability, and flexibility High level of customer service with a positive attitude Ability to retrieve and interpret documentation Ability to work in a team setting and independently under minimum supervision Exercises good judgment Skill Requirements Typing/computer keyboard Utilize computer software (specified above) Retrieve and compile information Verify data and information Organize and prioritize information/tasks Advanced mathematical concepts (fractions, decimals, ratios, percentages, graphs) Verbal communication Written communication Leadership and supervisory, managing people Physical Requirements Sitting for extended periods Extended periods viewing computer screen Walking Reading Speaking Hear/Listen Maintain regular, punctual attendance Writing Hazards Normal office environment All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. This role is not eligible for employer sponsorship of any kind. KLS Martin is a drug-free employer
