QA/RA Specialist

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