QMS Lead: Quality Systems, Audits & Training

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

Job summary

Highridge Medical LLC is seeking a QMS Manager to lead the Quality Management System, focusing on document control, training, audits, and data analysis to ensure regulatory compliance.

You will manage internal audits for ISO 13485, MDSAP, EU MDR and human tissue requirements, oversee a team of document control and training professionals, and drive continuous improvement within budgeted resources.

Qualifications

• Bachelor’s degree or equivalent years of experience.
• Minimum 5 years in a regulated industry.
• Familiar with ISO 13485, MDSAP, EU MDR and human tissue audits.
• Proficient with eQMS, SAP, Power BI and Excel.

Responsibilities

• Manage document control and training quality system processes.
• Lead internal and external audits for compliance.
• Monitor data sources and report quality performance to Top Management.
• Develop and implement improvements to the QMS.
• Manage departmental budget and resources.
• Hire, train, and develop QMS staff.

Skills

Internal audits

Document control

Training management

Quality data analysis

Quality systems

Leadership

eQMS experience

Education

B.S./B.A. degree or equivalent

Tools

eQMS applications

SAP

Power BI

Excel

Job description

Highridge Medical LLC is seeking a QMS Manager to lead the Quality Management System, focusing on document control, training, audits, and data analysis to ensure regulatory compliance.

You will manage internal audits for ISO 13485, MDSAP, EU MDR and human tissue requirements, oversee a team of document control and training professionals, and drive continuous improvement within budgeted resources.