DQS Inc. is an Equal Opportunity Employer. Minorities/Women/Veterans EQUAL EMPLOYMENT OPPORTUNITY (EEO) Qualified applicants are considered for employment without regard to race, religion, sex, national origin, age, marital status, sexual orientation, veteran status, disability, or other protected characteristic. The employer is subject to certain governmental recordkeeping and reporting requirements for the administration of civil rights laws and regulations. Right to Work Poster (English) EEO is the Law
Certification Specialist for Medical Devices
Location
Germany
Posted
8 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Certification Specialist for Medical Devices
DQS
Role Description - Bewertung der Technischer Dokumentationen (TD-Review) von Medizinprodukten unter MDR. - Durchführung von Audits nach MDR, ISO 13485, und ggf. MDSAP. - Beurteilung von Änderungen an Produkten und QM-Systemen, SSCPs, PSURs, und Vigilanz, im Rahmen der kontinuierlichen Überwachung. - Erstellung von Auditprogrammen und Stichprobenpläne, Zuweisung von Ressourcen, Verifizierung von Anträgen, Klassifizierung, Codierung, etc. - Mitwirkung an Konformitätsbewertungsverfahren, insbesondere bei komplexen oder neuartigen Medizinprodukten. - Fachlicher Austausch mit internen und externen Experten (z. B. Klinische Experten, Risikobewerter). - Unterstützung bei Behördenanfragen, ggf. Teilnahme an Inspektionen durch ZLG, DAkkS, und SCC. - Unterstützung von internen Verbesserungsmaßnahmen. - Finale Zulassung von Medizinprodukten. Qualifications - Abgeschlossenes Studium in einem relevanten Fachbereich (z. B. Medizintechnik, Biomedizin, Ingenieurwissenschaften, Naturwissenschaften). - Mehrjährige Berufserfahrung (> 4 Jahre) in der Entwicklung, Herstellung, Prüfung oder Qualitätssicherung von aktiven oder nichtaktiven Medizinprodukten. - Idealerweise mehrjährige (>10 Jahre) Berufserfahrung als Auditor und/oder Produktbewerter bei einer Benannten Stelle für die MDR-Verordnung (EU) 2017/745. - Tiefgehende Kenntnisse der MDR, ISO 13485, ISO 14971, ISO 10993, IEC 62304, IEC 62366-1, IEC 60601, ISO 14155, MDSAP Dokumente, sowie weiterer regulatorischer Anforderungen, MDCG-Leitlinien und Produktnormen. - Anerkannte und nachweisliche Qualifikationen als Lead Auditor für MDR, ISO 13485 und idealerweise MDSAP. - Ausgeprägte Fähigkeit zur Bewertung komplexer technischer und klinischer Sachverhalte. - Fließende Deutsch- und Englischkenntnisse in Wort und Schrift. - Hohes Maß an Eigenverantwortung, Objektivität und professioneller Kommunikation. - Bereitschaft zu internationaler Reisetätigkeit (nach Bedarf).
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