Director, Quality Systems & Compliance

Who We Are

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.

What You'll Do

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 Quality & Regulatory Affairs 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:
Director, Quality Systems & Compliance

Reports To:
Chief Regulatory, Quality & Clinical Affairs Officer

Location:
US, Remote

Position Summary 

The Director, Quality Systems & Compliance is a key leadership role responsible for driving the evolution, harmonization, and continuous improvement of the company’s global Quality Management System (QMS). This leader will oversee compliance activities across the organization, ensuring adherence to FDA, ISO, MDSAP, EU MDR, and other applicable regulatory requirements. The role will manage the internal and external audit programs, quality metrics, and governance processes to support operational excellence and regulatory readiness across all business units and sites. 

This individual partners closely with crossfunctional leadership—including Operations, R&D, Regulatory Affairs, Clinical Affairs, and Supply Chain—to strengthen the quality culture and ensure the QMS supports scalability, innovation, and sustained compliance. 

Key Responsibilities 

Quality Management System Leadership 

• Lead the design, implementation, and continuous improvement of a unified, enterprise-wide QMS across global sites and business units. 

• Drive QMS standardization, simplification, and integration following mergers, acquisitions, and organizational changes. 

• Ensure QMS documentation, procedures, records, and workflows meet global regulatory requirements and reflect industry best practices. 

• Serve as the process owner for major QMS subsystems (e.g., Document Control, Change Control, CAPA, Nonconformance, Complaints, Training, Supplier Quality Systems). 

Compliance & Audit Management 

• Develop and oversee the annual internal audit program, including risk-based audit planning, auditor qualification, and audit execution. 

• Lead preparation, readiness, and hosting of external audits/inspections, including FDA, ISO Notified Bodies, MDSAP, and customer audits. 

• Drive timely and effective closure of audit findings and regulatory observations. 

• Ensure compliance surveillance activities and regulatory intelligence are in place to proactively identify emerging requirements. 

Quality Metrics & Governance 

• Establish, track, and report enterprise-level quality metrics and KPIs through standardized dashboards and scorecards. 

• Lead monthly/quarterly management review processes, ensuring data integrity, trend analysis, and action tracking. 

• Provide meaningful insights and recommendations to executive leadership to support data-driven decision-making. 

Leadership & Cross-Functional Collaboration 

• Develop and mentor a high-performing Quality Systems & Compliance team. 

• Partner with IT to maintain and optimize electronic quality management systems (eQMS). 

• Collaborate with global operations, R&D, regulatory, and supply chain teams to embed quality into all phases of the product lifecycle. 

• Champion a culture of quality and compliance throughout the organization. 

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.

Qualifications 

Required 

• Bachelor’s degree in Engineering, Life Sciences, or related field. 

• 10+ years of quality and compliance experience in the medical device industry. 

• Deep understanding of FDA QSR (21 CFR Part 820), ISO 13485, MDSAP, EU MDR, and related global regulations. 

• Proven success leading internal and external audit programs. 

• Experience implementing or optimizing electronic QMS systems. 

• Demonstrated ability to lead cross-functional initiatives and drive systemic improvements. 

Preferred 

• Master’s degree in Engineering, Business, or related discipline 

• Certified Lead Auditor (ISO 13485 / MDSAP). 

• Experience in multi-site, global organizations. 

• Prior leadership in harmonizing or scaling QMS post-acquisition. 

Key Competencies 

• Strong leadership presence and ability to influence at all levels. 

• Strategic thinker with an operational mindset. 

• Excellent communication and facilitation skills. 

• Problem-solving and analytical capabilities, including data-driven decision making. 

• Ability to navigate ambiguity and manage competing priorities. 

“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.

What does creating better together mean to us at Enovis? Discover the “why” behind our purpose, values and behaviors:

 Our Enovis Purpose, Values and Behaviors on Vimeo

We offer a comprehensive benefits package that 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

Join us in creating better together.

EQUAL EMPLOYMENT OPPORTUNITY
Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria 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.