Compliance Systems Supervisor (34537)

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 Compliance Systems Supervisor is responsible for strategic implementation and support for RA/QMS and cross-functional process improvements to ensure compliance. This role oversees department administrative operations and provides governance over regulatory software compliance, including Computer Software Assurance (CSA) activities. 

This role ensures systems and processes are implemented and maintained in compliance with FDA, ISO, and global regulatory requirements. 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 

• Manage departmental administrative operations, including budget oversight, system access governance, onboarding strategy, and digital workspace optimization (e.g., SharePoint, Wrike).   

• Evaluate and interpret regulatory and quality data to inform strategic decisions and ensure continuous compliance within RA/QMS systems and processes.  

• Champion and drive data management strategies for the RA/QMS department, identifying opportunities for automation, efficiency, KPI monitoring, and risk mitigation.   

• Leverage Power BI and similar analytics tools to design, maintain, and present compliance dashboards that communicate system performance, KPI trends, and regulatory status to leadership and cross-functional stakeholders. 

• Facilitates and governs CSA validation activities. Ensure alignment with CSA principles, identify opportunities to simplify validation activities while maintaining compliance. 

• Own and maintain the CSA governance framework, including procedures, templates, and decision trees for risk-based assurance activities. 

• Lead risk assessments, including review of software features, functions, and intended use, to determine appropriate CSA strategies for new and existing systems 

• Maintains validation/assurance documentation, and ensures regulatory compliance (test protocols, traceability matrices). 

• Ensure audit readiness by maintaining compliant validation and quality system documentation and serving as a subject matter expert during regulatory and compliance audits 

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 automated 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 processes and improve system usability and compliance. 

• Develop and maintain CSA training and guidance to internal teams. 

• Track and report Compliance Team project metrics and KPIs to leadership, utilizing Power BI and other data visualization tools to present actionable insights in a clear and accessible format. 

Educational and Experience Requirements 

• 4-year degree plus 4 years of relevant experience 

• Previous work as a leader in a regulated company  

• Documented training to ISO 13485 

• Proficient user of Microsoft Power Platform, including Power BI; experience interpreting, analyzing, and presenting data and analytics using Power BI and similar tools 

• Strong knowledge of FDA regulations, ISO standards, and CSA methodologies. 

• Proven experience managing cross-functional projects in a regulated environment. 

• Excellent organizational, communication, and leadership skills. 

Knowledge, Skills, and Abilities 

• 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 
• Verbal communication 
• Written communication 

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.

KLS Martin is a drug-free employer