Complaint Handling & PMS Specialist

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

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.