Compliance Systems Supervisor

Job Details

Job Location:

Jacksonville, FL 32246

Position Type:
Full Time

Education Level: 4 Year Degree

Job Shift: Day

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 departmental administrative operations and provides governance over regulatory software compliance, including Computer Software Assurance (CSA) activities.

• 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.
• Facilitate and govern CSA validation activities, ensuring alignment with CSA principles and simplifying 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 of software features, functions, and intended use to determine appropriate CSA strategies for new and existing systems.
• Maintain validation/assurance documentation and ensure 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.

• 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.
• Scope of this role does not encompass business requirements, elicitation, process design, IT project management, or system configuration.

• 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.

• 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.

• 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.

• Typing/computer keyboard proficiency.
• Utilize computer software (specified above).
• Retrieve and compile information.
• Verify data and information.
• Organize and prioritize information/tasks.
• Verbal communication.
• Written communication.

• Sitting for extended periods.
• Extended periods viewing computer screen.
• Walking.
• Reading.
• Speaking.
• Hear/Listen.
• Maintain regular, punctual attendance.
• Writing.

• Normal office environment.

Paid parental leave; in‑house training and professional development opportunities; culture of creativity and innovation drawing on diverse perspectives and ideas to drive surgical innovation.

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.