Highridge Medical

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

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

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