Quality Specialist
Enovis · South Africa
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 Support
- 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 international operations leadership.
- Coordinate information requests, documentation needs, and project updates across multiple internal stakeholders.
- Support operational readiness for new product introductions, product transitions, customer onboarding, and compliance-related business changes.
- Contribute to local and global business reviews by providing regulatory, EH&S, quality, and operational compliance updates.
Supplier, Customer & External Stakeholder Support
- Support customer, hospital group, tender, vendor, and supplier documentation requirements linked to regulatory, quality, and compliance processes.
- Assist with customer onboarding documentation, product information requests, compliance questionnaires, and supplier approvals.
- Maintain professional relationships with external stakeholders, authorities, service providers, hospital groups, medical aid administrators, and internal global partners.
- Ensure responses are accurate, controlled, and aligned with company requirements before submission.
Compliance, Documentation & Governance
- Maintain controlled records for regulatory, quality, EH&S, audit, and operational compliance activities.
- Ensure processes and records are aligned with local laws, internal policies, global procedures, and applicable medical device requirements.
- Support post-market surveillance, complaint documentation, field actions, product holds, recalls, or other quality events where required.
- Drive disciplined document control, version management, filing, and follow-up of compliance actions.
- Champion ethical behaviour, transparency, audit readiness, and professional conduct across all compliance activities.
Training, Awareness & Continuous Improvement
- Coordinate relevant compliance, EH&S, quality, regulatory, and ISO-related training records and reminders.
- Support awareness sessions, process communication, and guidance for internal teams where required.
- Identify opportunities to simplify processes, improve documentation quality, reduce compliance risk, and strengthen operational discipline.
- Promote a culture of continuous improvement, accountability, safety, and compliance across the South African business.
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.