Einleitung In compliance with European MDD/MDR, FDA & other International Regulations, the Complaints Specialist will perform work under general management supervision. General scope of this position is to ensure compliance to the Complaints and Post Market Surveillance System with the responsibility of timely complaint initiation and assessment of regulatory geography reporting, complaint follow-up, coordination of complaint device returns, and collaboration with the cross-functional engineers and technicians for timely completion of the complaint investigation. This position requires frequent use and general knowledge of industry practices, techniques, and standards. Aufgaben Primary Responsibilities Processing of customer feedback ("complaints”), taking into account the requirements of ISO 13485 and all relevant medical device regulations Central recording of information by customers and sales/marketing Novanta about malfunctions and application problems. Problems with Novanta products (especially medical devices) as a complaint file Analysis of defective products (internal and customer, supplier complaints) using quality tools (8D report, 5WHY and others) Evaluation of the analysis results to develop and initiate corrective and preventive measures Evaluation of the analysis results with regard to complaint category (A, B, C or D), information to RA and QMB/safety commissioned for categories C and D Reporting to the customer (and the relevant internal areas) Documentation of processes in accordance with regulatory requirements Regular evaluation of processes (monthly and annually) Processing customer feedback on non-medical devices (taking into account the requirements from ISO 9001) Recording, analyzing, evaluating and documenting customer feedback on non-medical products Close cooperation with Quality Operations Supervisor and quality engineer Supervisor Working with SAP – different operations (e.g. complaints, material, etc.) Participates in meetings for the launch of new projects Cooperation on customer, internal quality audits Different types of analysis (scrap, error rate). Qualifikation Ausbildung, Erfahrung und Kompetenzen Bachelor mit Fachrichtung Maschinenbau oder Elektrotechnik oder vergleichbare Technikerausbildung mit Berufserfahrung Kenntnisse der Normen EN ISO 13485 und ISO 9001 zwingend notwendig Kenntnisse der Qualitätsinstrumente (5Why, Ishikawa, 8D-Bericht) wünschenswert Orientierung in der technischen Dokumentation MS-Office-Anwendungen Konzentrierter, zuverlässiger und selbständiger Arbeitsstil Aktiver Ansatz und Beteiligung am Innovationsprozess Strenge Einhaltung der Qualitäts-, Sicherheits- und Umweltvorschriften und Umsetzung der Qualitätsrichtlinien Sehr gute deutsche und englische Sprachkenntnisse zwingend erforderlich Reisebereitschaft Die Bereitschaft zu Dienstreisen zu allen Novanta-Standorten und Geschäftskontakten von Novanta (weniger als 10% der Arbeitszeit)