Auf einen Blick
- Aufgaben: Untersuche Kundenbeschwerden und verbessere Produkte kontinuierlich.
- Unternehmen: Innovatives Unternehmen im Bereich der Medizintechnik mit dynamischer Kultur.
- Vorteile: Flexible Arbeitszeiten, umfassende Schulungen und ein modernes Arbeitsumfeld.
- Weitere Informationen: Hohe Autonomie und spannende Entwicklungsmöglichkeiten in einem schnell wachsenden Unternehmen.
- Warum dieser Job: Gestalte die Zukunft der robotergestützten Chirurgie und mache einen echten Unterschied.
- Qualifikationen: Bachelor-Abschluss und 3-5 Jahre Erfahrung im Qualitätsmanagement von Medizinprodukten.
Das prognostizierte Gehalt liegt zwischen 56700 - 69300 CHF pro Jahr.
For this temporary mission
As part of the Quality & Regulatory department, the Complaint Handling & PMS Specialist is responsible for investigation of product and customer complaints.
He is carrying “voice of the customers” into product development and CAPA boards to drive for continuous products and services improvement.
He has direct impact on Distalmotion products quality improvement and on customers satisfaction.
Duties and Responsibilities
Complaint Handling
- Own and continuously improve the complaint handling tool and process to ensure both reportability compliance, customer satisfaction and drive product continuous improvement.
- Daily review of the complaint database for reportability evaluation, in case of potential reportable event, to elevate the case to the post-market Surveillance Specialist and the Head of QA/RA.
- Liaise with Clinical Specialist and/or Field Service for complaint records completeness.
- Ensure timely investigation and closure of complaints.
- Involve on related CAPA, R&D, PMO, Training reviews to report on product complaints.
- Lead monthly Customer Complaint Board, providing recent complaint overview to Distalmotion’s management.
- Report on product complaint data for Post Market Surveillance reviews.
- Lead the writing of customer complaint response letter in collaboration with the PEMA team
Product Support
- Manage the return of failed products from the field.
- Lead cross-functional teams for timely and effective investigation of returned products, including performing investigations of contaminated products in the laboratory environment.
- Support in the update of work instructions for the service, repair, and testing processes.
- Support Field Service and Product Support teams for implementation of CAPA and Field Actions to address customer complaints.
Other duties as assigned, for example: Finished Product Release, monitor compliance with procedures, perform internal audit, and update the QMS documentation accordingly
Work Experience and Education requirements
- Bachelor's degree; advanced degree preferred
- 3 to 5 years of similar QA experience in a medical device company developing, manufacturing and marketing technically complex equipment, including hardware, software and mechanics.
Knowledge, Skills & Abilities required
- Significant knowledge of medical devices Quality Management System (ISO-13485, 21CFR part 820 quality) and regulatory landscape (MDD, MDR)
- Experience in Complaint handling is a must
- Risk management as per ISO 14971
- Good communication skill to share Quality and Customer Focus vision within the company.
- English and French fluent
What we offer
- A dynamic, innovative environment with cutting-edge medical technology that is shaping the future of robotic surgery.
- Fast-growing Company where innovation meets agility.
- Structured onboarding program and training, ensuring a confident start.
- High degree of autonomy and flexibility.
- #J-18808-Ljbffr
Complaint Handling & PMS Specialist Arbeitgeber: Distalmotion SA
Distalmotion bietet eine dynamische und innovative Arbeitsumgebung, in der Sie aktiv zur Verbesserung der Produktqualität und Kundenzufriedenheit beitragen können. Mit einem strukturierten Einarbeitungsprogramm und umfangreichen Schulungsmöglichkeiten fördern wir das Wachstum unserer Mitarbeiter und bieten Ihnen die Flexibilität, Ihre Ideen einzubringen. Arbeiten Sie mit modernster Medizintechnologie in einem schnell wachsenden Unternehmen, das Innovation und Agilität vereint.
