QMS Specialist II: Flexible Hours & Impactful Compliance

KLS Martin Group; Jacksonville (FL); Hybrid; USD 75,000 - 110,000; Full time

Job summary

KLS Martin Group is seeking a Quality Management System Specialist II to advance the QMS for medical devices in a hybrid on-site/local remote setting in Jacksonville, FL. You will lead complex QMS processes, drive audits, manage risk, and guide cross-functional teams to implement compliant improvements.

This role requires strong knowledge of ISO 13485 and FDA regulations, plus experience with CAPA, document control, and data analysis. You will mentor junior staff and report to the QMS leadership.

Qualifications

• Knowledge of ISO 13485 and FDA regulations.
• 4-year degree plus 3–5 years in a regulated industry.
• 5 years of experience in a regulated industry.
• Proficient with MS Office applications and intermediate Excel.

Responsibilities

• Lead and support QMS processes and audits.
• Develop and maintain QMS documents and procedures.
• Analyze quality data and report trends (NCMRs, CAPA).
• Coordinate calibration and supplier controls.
• Lead corrective and preventive actions and investigations.
• Support Management Review meetings.

Skills

QMS knowledge

Auditing

Risk assessment

Communication

Team collaboration

Education

Bachelor's degree

Tools

MS Excel

SharePoint

MS Office

Job description

KLS Martin Group is seeking a Quality Management System Specialist II to advance the QMS for medical devices in a hybrid on-site/local remote setting in Jacksonville, FL. You will lead complex QMS processes, drive audits, manage risk, and guide cross-functional teams to implement compliant improvements.

This role requires strong knowledge of ISO 13485 and FDA regulations, plus experience with CAPA, document control, and data analysis. You will mentor junior staff and report to the QMS leadership.