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
ROLE PURPOSE
The Quality Specialist is responsible for supporting the One Enovis business in South Africa by coordinating environmental, health and safety, regulatory, product registration, quality system and compliance-related requirements across the organisation.
This role acts as a key coordination point between local business needs and global operations expectations, ensuring that Enovis South Africa remains compliant, audit-ready, well documented, and aligned with internal policies, ISO requirements, product registration obligations, and applicable healthcare industry regulations.
The role combines regulatory coordination, ISO implementation support, EH&S governance, document control, audit preparation, stakeholder communication, and cross-functional project support to enable safe, compliant, and efficient business operations.
As a Cape Town-based One Enovis role, the Quality Specialist will play an important part in strengthening operational compliance, supporting product access to market, reducing regulatory risk, and helping teams create better patient outcomes through disciplined governance and execution.
KEY RESPONSIBILITIES
Regulatory & Product Registration Coordination
Coordinate all regulatory and product registration requirements for Enovis South Africa.
Support product registrations, renewals, amendments, listing updates, and related documentation requirements.
Coordinate NAPPI codes, hospital registrations, medical aid registrations, billing requirements, and customer-specific product access documentation.
Maintain accurate regulatory records, certificates, product information files, and registration trackers.
Work with global Regulatory, Quality, Operations, and Product teams to obtain required technical, clinical, quality, and compliance documentation.
Monitor registration expiry dates, submission timelines, and follow-up actions to prevent delays in product availability.
ISO Implementation, Quality Systems & Audit Readiness
Coordinate ISO implementation activities and support the maintenance of ISO-aligned quality management processes.
Prepare, coordinate, and support internal and external audit requirements.
Maintain audit schedules, evidence files, corrective action trackers, and compliance documentation.
Support the development, review, approval, and control of SOPs, work instructions, policies, forms, and quality documents.
Follow up on audit findings, non-conformances, corrective and preventive actions, and continuous improvement opportunities.
Ensure records are complete, accessible, accurate, and audit-ready at all times.
Environmental, Health & Safety Coordination
Coordinate local EH&S activities, initiatives, documentation, and reporting requirements.
Support workplace safety programmes, risk assessments, incident reporting, corrective actions, and safety communication.
Help maintain safe office, warehouse, field, and operational practices in line with company policies and local requirements.
Coordinate EH&S training records, safety awareness activities, workplace inspections, and follow-up actions.
Escalate EH&S risks, incidents, or gaps to local leadership and international operations leadership when required.
Cross-Functional Coordination & One Enovis Suppor t
Support the One Enovis model by working across Surgical, Prevention & Recovery, Operations, Quality, Regulatory, Commercial, and Customer Service teams.
Ensure clear communication between local business teams and…