QMS Manager

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

QMS Manager Job Summary:

Responsible for implementing, maintaining and managing the Quality Management System (QMS) as it relates to Document Control, Training, Audits (internal and external) as well quality data analysis and trending to ensure compliance to applicable quality systems standards and regulations. The incumbent leads the Management of the internal audit, document control and training solutions and monitors those quality processes through data trending and analysis. The incumbent identifies opportunities and implements processes for improvement to assure conformance with the established requirements and best practices. The incumbent leads interactions with various functions, and stakeholders (internal or external) to accomplish compliance and implementation of the quality management system deliverables. The incumbent manages and directs a group of document control and training professionals dedicated to maintaining and implementing systems to support the quality processes for document control and training. Responsible for managing and maintaining an operating budget.

Principal Duties and Responsibilities:

• Manage and maintain document control and training quality system processes in compliance with the applicable standards and regulations.
• Manages and conducts internal audits within the organization for ISO 13485, MDSAP, EU MDR, and human tissue requirements.
• Provides leadership in the identification and implementation of improvements for internal audits, document control and training quality systems processes
• Actively monitors data sources and collects data to report to Top Management on quality process/systems performance and to identify improvement opportunities
• Develops and implements processes, procedures and instructions to maintain the effectiveness of the QMS to improve it when necessary
• Support in planning and actions related to external audits (regulatory agencies). Correspond with these agencies regarding compliance issues, as needed
• Hire, train, develop, and manage personnel to effectively support and continuously improve QMS
• Support in the development and deployment of automated system solutions for systems related to QMS
• Maintains departmental budget within prescribed limits

Expected Areas of Competence (i.e., knowledge, skills, and abilities):

• Proven ability and familiar with all aspects and elements of internal and external audit requirements related to ISO 13485, MDSAP, EU MDR and human tissue.
• Complete understanding of requirements as related to all aspects of document management systems and processes, control of documents thru its life cycle.
• Basic understanding of quality system including but not limited to Design and development, labeling, CAPA, management responsibility, resource management, product realization and measurement, analysis and improvement processes.
• Ability to work within a team environment and build relationships outside of the department as well as outside the company.
• Proven ability to direct, build, develop and manage a team of professionals
• Ability to deal with difficult situations with tact, professionalism, and discretion
• Demonstrated technical expertise and aggressiveness as related to implementation and maintenance of a quality management system.
• Ability to work with minimum supervision and consider options to complete quality work
• Excellent communication skills (both oral and written), and ability to work with employees at all levels of the organization.
• Must be proficient in eQMS applications, SAP, Microsoft Office, Power BI, excel

Education/Experience Requirements:

• B.S/B.A degree and/or equivalent years of experience.
• Minimum 5 years’ experience in a regulated industry

Salary Range $115,000- $130,000 + Incentive Bonus

Welcome to the Highridge Medical's Career Page.

Highridge Medical is committed to improving spine care by partnering with the surgeon community to drive innovation. The company has a compelling and comprehensive portfolio supported by extensive clinical evidence, including solutions for complex spine, motion preservation, minimally invasive surgery, biologics, and enabling technologies.

For additional information, please visit www.highridgemedical.com.