Associate Manager, Quality Management System (QMS)

Enovis•Austin, TX

22h

About The Position

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. At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients and take pride in the pursuit 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. Why work at Enovis? See for yourself. As a key member of the QA 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/High Level Position Summary: The Associate Manager, Quality Management System (QMS), is responsible for the oversight, improvement, and strategic development of key QMS elements to ensure compliance with applicable regulatory standards and drive a culture of continuous improvement. This role serves as the owner of core quality system processes including Nonconformance, CAPA, Change Management, Risk Management, and Internal/External Audits. The Associate Manager will also support the monitoring of quality data and metrics to identify trends, drive systemic improvements, and maintain overall QMS health and readiness for regulatory inspections. In addition, the role provides leadership and support during internal, external, and regulatory audits.

Requirements

Essential Duties and Responsibilities: Serve as process owner for key QMS elements, including but not limited to Nonconformance, CAPA, Change Management, Risk Management, and Audit programs.
Drive continuous improvement of the QMS through proactive identification of gaps, process optimization, and implementation of best practices.
Lead and support cross-functional teams in the execution and closure of CAPAs, ensuring timely and effective root cause analysis and implementation of corrective actions.
Monitor and analyze quality data, trends, and system performance to identify opportunities for improvement and enhance QMS effectiveness.
Develop and maintain QMS metrics dashboards and performance indicators to ensure ongoing visibility and accountability.
Support the planning, execution, and follow-up of internal audits; coordinate external and third-party audits, including FDA and ISO inspections.
Provide leadership support and serve as a point of contact during regulatory inspections and audits.
Collaborate with functional stakeholders (e.g., QA Operations, Manufacturing, Regulatory Affairs, Engineering) to ensure alignment and integration of QMS requirements across the organization.
Contribute to the training, coaching, and development of quality personnel and stakeholders involved in QMS processes.
Maintain up-to-date knowledge of applicable quality and regulatory standards, including ISO 13485, 21 CFR Part 820, and other relevant requirements.
Currently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.

Responsibilities

Serve as process owner for key QMS elements, including but not limited to Nonconformance, CAPA, Change Management, Risk Management, and Audit programs.
Drive continuous improvement of the QMS through proactive identification of gaps, process optimization, and implementation of best practices.
Lead and support cross-functional teams in the execution and closure of CAPAs, ensuring timely and effective root cause analysis and implementation of corrective actions.
Monitor and analyze quality data, trends, and system performance to identify opportunities for improvement and enhance QMS effectiveness.
Develop and maintain QMS metrics dashboards and performance indicators to ensure ongoing visibility and accountability.
Support the planning, execution, and follow-up of internal audits; coordinate external and third-party audits, including FDA and ISO inspections.
Provide leadership support and serve as a point of contact during regulatory inspections and audits.
Collaborate with functional stakeholders (e.g., QA Operations, Manufacturing, Regulatory Affairs, Engineering) to ensure alignment and integration of QMS requirements across the organization.
Contribute to the training, coaching, and development of quality personnel and stakeholders involved in QMS processes.
Maintain up-to-date knowledge of applicable quality and regulatory standards, including ISO 13485, 21 CFR Part 820, and other relevant requirements.