Quality & Complaint Lead, Med Devices (CAPA & PMS)

Distalmotion SA; Lavamünd; Hybrid; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

Distalmotion SA is seeking a Complaint Handling & PMS Specialist to investigate product and customer complaints, acting as the voice of the customer for product development and CAPA boards. The role sits within Quality & Regulatory and requires strong knowledge of ISO 13485 and regulatory frameworks, plus experience in complaint handling and risk management.

The candidate will lead the Customer Complaint Board, manage CAPA inputs, and collaborate with R&D, PMO and Training teams to improve

Qualifikationen

• 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.
• Knowledge of ISO 14971 risk management.
• Strong communication abilities to share Quality and Customer Focus vision.

Aufgaben

• Own and continuously improve the complaint handling tool and process to ensure reportability compliance, customer satisfaction and drive product improvement.
• Lead monthly Customer Complaint Board and report on product complaint data for Post Market Surveillance reviews.
• Lead the writing of customer complaint response letters with the PEMA team.
• Manage return of failed products and coordinate cross-functional investigations for timely closure.
• Support in updates to work instructions for service, repair, and testing processes.

Kenntnisse

Quality Management System

Regulatory knowledge

Complaint handling

Risk management

Communication skills

English proficiency

French proficiency

Ausbildung

Bachelor's degree; advanced degree preferred

Jobbeschreibung

Distalmotion SA is seeking a Complaint Handling & PMS Specialist to investigate product and customer complaints, acting as the voice of the customer for product development and CAPA boards. The role sits within Quality & Regulatory and requires strong knowledge of ISO 13485 and regulatory frameworks, plus experience in complaint handling and risk management.

The candidate will lead the Customer Complaint Board, manage CAPA inputs, and collaborate with R&D, PMO and Training teams to improve