Computer Software Assurance Supervisor

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., 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.

• 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

• 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

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