Job Opportunities API

Your Role As a QA/RA Specialist, you are an all ‑ round contributor within our QA/RA team. In this position, your primary focus lies on document management, CAPA, and product registrations. You play an active role in maintaining a compliant Quality Management System (QMS) by managing controlled documentation, handling quality issues through CAPA, and supporting regulatory registrations for our In ‑ Vitro Diagnostic Medical Devices. You work closely with internal stakeholders and external partners to ensure accuracy, traceability, and regulatory compliance. Your Responsibilities • Manage, store, and track controlled quality documents and records within the QMS • Ensure documents are accurate, complete, and compliant with regulatory and internal requirements • Process documents for review, revision, approval, and controlled release • Coordinate document changes and ensure correct version control and distribution • Archive obsolete or inactive documents in accordance with retention requirements • Initiate, manage, and follow up on CAPAs, including root cause analysis and trend monitoring • Support the investigation and documentation of quality issues and non ‑ conformities • Maintain product registrations and registration-related documentation • Liaise with OEM manufacturers, distributors, and regulatory authorities • Support regulatory submissions and product changes Education & Experience • Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field • 2–4 years of relevant experience in QA/RA within medical devices or IVD • Hands ‑ on experience with document control and CAPA processes • Familiarity with ISO 13485 and medical device regulations (IVDR preferred) • Experience with regulatory submissions and interactions with authorities is an advantage • Strong analytical, communication, and organizational skills Why Join Us? • A vital role in a healthy and future-focused organization • Clear growth paths via personalized competence development models • Opportunities to innovate and make real impact on safer healthcare • A positive work culture that encourages initiative and knowledge sharing • Market-competitive salary and a dynamic, flexible work environment