QMS Lead: ISO Compliance, Audits & Training

Highridge Medical; Westminster (MD); On-site; USD 115,000 - 130,000; Full time

Benefits offered by this job

Incentive Bonus

Job summary

Highridge Medical is seeking a QMS Manager to lead the quality management system, document control, and training functions. You will drive internal audits, data analysis, and process improvements to ensure compliance with ISO 13485 and related regulatory standards.

The role requires guiding cross-functional teams, managing budgets, and deploying automated QMS solutions. Strong communication and leadership are essential for success in this position.

Qualifications

• Bachelor’s degree and 5+ years in a regulated environment.
• Experience leading document control, audits and training.
• Familiar with ISO 13485, MDSAP, EU MDR, and human tissue requirements.

Responsibilities

• Manage document control and training processes to comply with standards.
• Lead internal audits for ISO 13485, MDSAP, EU MDR, and tissue requirements.
• Monitor quality data and trends to identify improvement opportunities.
• Develop procedures to maintain QMS effectiveness and support external audits.

Skills

Quality management

Leadership

Data analysis

Communication

Team management

Regulatory thinking

Problem solving

Education

B.S./B.A.

Tools

SAP

Power BI

Excel

Microsoft Office

eQMS applications

Job description

Highridge Medical is seeking a QMS Manager to lead the quality management system, document control, and training functions. You will drive internal audits, data analysis, and process improvements to ensure compliance with ISO 13485 and related regulatory standards.

The role requires guiding cross-functional teams, managing budgets, and deploying automated QMS solutions. Strong communication and leadership are essential for success in this position.