QMS Manager: ISO 13485 Audits, Training & Data

HIGHRIDGE Inc.; Westminster (CO); On-site; USD 115,000 - 130,000; Full time

Benefits offered by this job

Incentive bonus

Job summary

HIGHRIDGE Inc. in Westminster, Colorado, seeks a QMS Manager to implement and maintain the Quality Management System, overseeing document control, training, audits, and data analysis to ensure compliance with ISO 13485, MDSAP, EU MDR and related regulations.

The role leads a team of document control and training professionals, drives continuous improvement, manages external audits, and partners with cross-functional stakeholders while maintaining an operating budget.

Qualifications

• B.S./B.A. degree or equivalent years of experience in a regulated context.
• Experience with ISO 13485, MDSAP, EU MDR and human tissue requirements preferred.
• Strong understanding of document management systems and life-cycle control.
• Excellent communication across levels and teams.

Responsibilities

• Manage and maintain document control and training quality system processes in compliance with applicable standards and regulations.
• Conduct internal audits for ISO 13485, MDSAP, EU MDR, and human tissue requirements.
• Lead improvements for internal audits, document control and training quality systems processes.
• Monitor data sources and report quality performance to Top Management to identify improvements.
• Develop and deploy processes, procedures and instructions to maintain and improve the QMS.

Skills

eQMS

SAP

Power BI

Excel

Microsoft Office

Education

Bachelor's degree

Tools

eQMS applications

Job description

HIGHRIDGE Inc. in Westminster, Colorado, seeks a QMS Manager to implement and maintain the Quality Management System, overseeing document control, training, audits, and data analysis to ensure compliance with ISO 13485, MDSAP, EU MDR and related regulations.

The role leads a team of document control and training professionals, drives continuous improvement, manages external audits, and partners with cross-functional stakeholders while maintaining an operating budget.