> Jobs > Product Support Quality Engineer
04.09
2024

Product Support Quality Engineer

As part of the Customer Experience department, the Product Support Quality Engineer 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 complaint handling tool and process to ensure both reportability compliance, customer satisfaction and drive product continuous improvement.

  • Daily review of complaint database for reportability evaluation.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 complaint overview to Distalmotion's management.

  • Report on product complaint data for Post Market Surveillance reviews.


Product Support:

  • Manage return of failed products from the field.Lead cross-functional teams for timely and effective investigation of returned products, including performing investigation of contaminated products in laboratory environment.

  • Create and maintain 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:

  • 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.

  • Degree in Engineering.


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.


More information and application