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 and organizational skills and ability to work in a team-oriented environment.

Must have a minimum of 5years of experience in Medical Device Development

Must havea minimum of 5 years of experiencein quality assurance practices.

Must have a minimum of 5 years of experience in PLM and ERP system

Either 3 years of direct management or 5years of project management

Preferred Experience

Experience in Oracle Agile PLM, Oracle EBS, and Compliance Wire

Project Management Professional or other Project Management Credentials

Education

Bachelor Degree in a Technical Field

Additional Business Degree Preferred (Minor, BBA or MBA)

Work Environment and Physical Demands

Office job with up to 25% travel

“Creating better together”.It’s the Enovis purpose, and it’s what drives us and empowers us every day on a global scale. We know that the power to create better – for our customers, our team members, and our shareholders – begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

Watch this short video and discover what creating better together means to us at Enovis:

Our Enovis Purpose, Values and Behaviors on Vimeo

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit www.enovis.com to learn more.

EQUAL EMPLOYMENT OPPORTUNITY:

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role withEnovis.

ABOUT ENOVIS™

EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.

Quality Systems Manager

ENOVIS

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