Quality Systems Manager

Job Description:

At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence — with the goal of transforming medical technology as we know it. 

Because that’s how we change the lives of patients for the better. And that’s how we create better together. 

As a key member of the Shared Services Department, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. 

Job Title: 

Quality Systems Manager 

Reports To: 

Director, RA/QA Shared Services 

Location: 

DJO Dallas Headquarters 

Business Unit Description:  

DJO RAQA Shared Services 

Job Title/High Level Position Summary: 
 

The Quality Systems manager will lead a team of Document Control coordinators to oversee the daily service, maintenance and improvement of Enovis’ Product Lifecycle Management (PLM) System, Learning Information Management System (LIMS), and the Data Governance for Product lifecycle data into our Engineering Resource Planning (ERP) System.   

Key Responsibilities: 
 

• Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. 

• Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system.  

• Assures procedures are in place to classify and maintain records.  

• Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements.  

• May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers.  

• May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched.  

• May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.  

• Receives assignments in the form objectives with goals and the process by which to meet goals.  

• Directs subordinates on predetermined work assignments which are completed using established guidelines, procedures and policies. Supervises  

• Support track employees and may occasionally perform similar work as their subordinates. 

• Support the Quality Business Intelligence Function in troubleshooting and sourcing product data 

Minimum Basic Qualifications: 
 

Experience 

• Effective communication