Quality Assurance Specialist – QMS & Compliance (m/f/d)

About the Company We are looking for a Quality Assurance Specialist – QMS an equivalent technical qualification combined with strong relevant QA experience may also be considered. Approximately 3–5 years of relevant experience in Quality Assurance, Quality Systems, Supplier Quality or Quality Management, preferably in the medical-device industry. Required Skills Practical knowledge of ISO 13485 and working knowledge of EU MDR. Experience with internal audits and/or supplier audits. Practical experience with CAPA, nonconformities/deviations and structured root-cause investigation. Understanding of complaint handling and the interface with Regulatory Affairs/Vigilance. Strong analytical, problem-solving and process-improvement capability. Ability to assess objective evidence critically and constructively challenge inadequate investigations, corrective actions or processes. Structured, precise and independent working style with strong documentation and report-writing skills. Strong communication and stakeholder-management capability and confidence interacting with process owners and external suppliers. Strong professional English; Very good German is strongly preferred. Preferred Skills Supplier-audit and supplier-quality experience. Internal Auditor or Lead Auditor training/qualification and knowledge of ISO 19011. Experience with Notified Body audits or regulatory inspections. Class III and/or implantable medical-device experience. Complaint trending, Vigilance/PMS interface, FDA QMSR or MDSAP experience. Experience with process mapping, Lean or other structured continuous-improvement methodologies. Equal Opportunity Statement We are committed to diversity and inclusivity.