Complaint Handling & PMS Specialist

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.

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.

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