Associate Manager, Quality Management System (QMS)

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 Quality Assurance team, 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:

Associate Manager, Quality Management System (QMS)

Reports To:

Sr Director, Quality Assurance

Location:

Austin, TX

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.

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.

Minimum Basic Qualifications:

• Bachelor's degree in a scientific or engineering discipline required.

• 5+ years of experience in quality assurance or quality systems in a regulated industry (medical device, aerospace, automotive, or similar).

• Experience with ISO 13485 and FDA QSR requirements required.

• Experience in QMS process ownership, especially CAPA, Nonconformance, Change Management, and Audit processes.

• Prior experience supporting or leading internal/external audits; experience with regulatory agency inspections preferred.

Desired Characteristics:

• Supervisory or leadership experience preferred.

• Proficient in Microsoft Office Suite; experience with QMS platforms such as Agile PLM, Oracle, or similar systems preferred.

• Strong communication, organizational, and interpersonal skills with the ability to work cross-functionally.

• Strong analytical skills with experience in monitoring quality data and driving systemic improvements.

"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

We offer a comprehensive benefits package which includes:

• Medical Insurance

• Dental Insurance

• Vision Insurance

• Spending and Savings Accounts

• 401(k) Plan

• Vacation, Sick Leave, and Holidays

• Income Protection Plans

• Discounted Insurance Rates

• Legal Services

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 with Enovis.

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.For more information about Enovis, please visit www.enovis.com.

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.