Complaint Handling & PMS Specialist

Distalmotion·Épalinges, Switzerlandmid

En corto

→Especialista en manejo de quejas y vigilancia postmercado para dispositivos médicos.
→Investiga quejas, gestiona devoluciones de productos y lidera tablas de mejora continua con equipos multidisciplinarios.
→Destacado: Impacto directo en calidad de productos y satisfacción del cliente mediante el "voz del cliente".

English and French fluent

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¿Qué piden?

✓Grado universitario; posgrado preferido.
✓3 a 5 años de experiencia en calidad en empresas de dispositivos médicos.
✓Conocimiento práctico de ISO 13485, 21CFR Part 820, MDD/MDR.
✓Experiencia comprobada en manejo de quejas y gestión de CAPA.
✓Habilidades sólidas de comunicación y trabajo en equipo multidisciplinario.
✓Fluidez en inglés y francés.

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ISO-1348521CFR Part 820MDDMDRISO 14971CAPAPMSQMSR&DPMO

¿A quién escribirle en Distalmotion?

Tu dossier gratis identifica a las personas que te entrevistarían — con su background, qué valoran y cómo escribirles para destacar antes de aplicar.

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 escalate 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. Requirements 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. Benefits 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. Find Jobs in Switzerland on Arbeitnow

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