{"id":2919407,"url":"https://alion.io/job/enovis-quality-specialist","title":"Quality Specialist","company":{"id":5048,"name":"Enovis","domain":"enovis.com","url":"https://alion.io/company/enovis","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":82,"open_postings":19,"ghost_share":0,"stale_share":0.737,"repost_share":0,"time_to_fill_p50_days":24,"computed_at":"2026-10-22T06:10:10Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["South Africa"],"countries":["ZA"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-20T11:32:51Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-22T00:08:03Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Who We Are\nABOUT ENOVIS™\nEnovis 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.\nWhat You'll Do\nROLE PURPOSE\nThe 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.\nThis 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.\nThe 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.\nAs 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.\nKEY RESPONSIBILITIES\nRegulatory & Product Registration Coordination\nCoordinate all regulatory and product registration requirements for Enovis South Africa.\nSupport product registrations, renewals, amendments, listing updates, and related documentation requirements.\nCoordinate NAPPI codes, hospital registrations, medical aid registrations, billing requirements, and customer-specific product access documentation.\nMaintain accurate regulatory records, certificates, product information files, and registration trackers.\nWork with global Regulatory, Quality, Operations, and Product teams to obtain required technical, clinical, quality, and compliance documentation.\nMonitor registration expiry dates, submission timelines, and follow-up actions to prevent delays in product availability.\nISO Implementation, Quality Systems & Audit Readiness\nCoordinate ISO implementation activities and support the maintenance of ISO-aligned quality management processes.\nPrepare, coordinate, and support internal and external audit requirements.\nMaintain audit schedules, evidence files, corrective action trackers, and compliance documentation.\nSupport the development, review, approval, and control of SOPs, work instructions, policies, forms, and quality documents.\nFollow up on audit findings, non-conformances, corrective and preventive actions, and continuous improvement opportunities.\nEnsure records are complete, accessible, accurate, and audit-ready at all times.\nEnvironmental, Health & Safety Coordination\nCoordinate local EH&S activities, initiatives, documentation, and reporting requirements.\nSupport workplace safety programmes, risk assessments, incident reporting, corrective actions, and safety communication.\nHelp maintain safe office, warehouse, field, and operational practices in line with company policies and local requirements.\nCoordinate EH&S training records, safety awareness activities, workplace inspections, and follow-up actions.\nEscalate EH&S risks, incidents, or gaps to local leadership and international operations leadership when required.\n\nCross-Functional Coordination & One Enovis Suppor t\nSupport the One Enovis model by working across Surgical, Prevention & Recovery, Operations, Quality, Regulatory, Commercial, and Customer Service teams.\nEnsure clear communication between local business teams and international operations leadership.\nCoordinate information requests, documentation needs, and project updates across multiple internal stakeholders.\nSupport operational readiness for new product introductions, product transitions, customer onboarding, and compliance-related business changes.\nContribute to local and global business reviews by providing regulatory, EH&S, quality, and operational compliance updates.\nSupplier, Customer & External Stakeholder Support\nSupport customer, hospital group, tender, vendor, and supplier documentation requirements linked to regulatory, quality, and compliance processes.\nAssist with customer onboarding documentation, product information requests, compliance questionnaires, and supplier approvals.\nMaintain professional relationships with external stakeholders, authorities, service providers, hospital groups, medical aid administrators, and internal global partners.\nEnsure responses are accurate, controlled, and aligned with company requirements before submission.\nCompliance, Documentation & Governance\nMaintain controlled records for regulatory, quality, EH&S, audit, and operational compliance activities.\nEnsure processes and records are aligned with local laws, internal policies, global procedures, and applicable medical device requirements.\nSupport post-market surveillance, complaint documentation, field actions, product holds, recalls, or other quality events where required.\nDrive disciplined document control, version management, filing, and follow-up of compliance actions.\nChampion ethical behaviour, transparency, audit readiness, and professional conduct across all compliance activities.\n\nTraining, Awareness & Continuous Improveme nt\nCoordinate relevant compliance, EH&S, quality, regulatory, and ISO-related training records and reminders.\nSupport awareness sessions, process communication, and guidance for internal teams where required.\nIdentify opportunities to simplify processes, improve documentation quality, reduce compliance risk, and strengthen operational discipline.\nPromote a culture of continuous improvement, accountability, safety, and compliance across the South African business.\nEQUAL EMPLOYMENT OPPORTUNITY\nEnovis 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.","description_format":"text","description_chars":6707,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Orthopedic & Spine Implants","Mobility & Assistive Devices"],"lifecycle":[{"event":"open","at":"2026-10-20T11:32:51Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":1,"expected_fill_days":24,"reasons":["conf:6","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-22T06:10:10Z"},"pay":null,"html_url":"https://alion.io/job/enovis-quality-specialist","json_url":"https://alion.io/job/enovis-quality-specialist.json","meta":{"generated_at":"2026-10-22T10:18:05Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":7526,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-23T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":5048},"rest":"https://alion.io/mcp/rest/get_company?id=5048"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fenovis-quality-specialist"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fenovis-quality-specialist"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fenovis-quality-specialist"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/enovis-quality-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fenovis-quality-specialist"}]}