Director, Quality Systems & Compliance

Enovis

1d•Remote

About The Position

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. 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.

Requirements

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.

Nice To Haves

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.

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.