Complaint Handling Specialist a Eysins

Your Role :

As part of the Global Services for the Device business department, the MD complaint handling Specialist is responsible for the complaint handling activity and product support of the marketed delivery systems for injectable drugs (drug injectors, reconstitution systems, connected devices).

Your main tasks:

• Running the investigation on medical device returned from the field and performing root cause analysis by developing and conducting test on complaint sample.
• Requesting and reviewing investigation report from supplier as needed.
• Ensuring accurate reporting of test and investigation result in the related complaint record.

In all actions, you should demonstrate a primary commitment to patient safety and product quality by maintaining compliance to quality processes and procedures. You will participate and maintain quality documentation up to date and prepare information with regard to product return and feedback as requested.

You will able to:

• collaborate with all relevant engineering, manufacturing and other operations functions to ensure product quality.
• Develop and maintain knowledge of our medical device portfolio and provide support to Merck subsidiaries to enhance patient' satisfaction.
• Identify and implement complaint process improvement.

Who you are:

• Bachelor degree in science or related field
• Knowledge of medical device regulations, ISO 13485, 21 CFR 820, ISO 14971
• Experienced with medical devices
• Proficient with personal computers and with MS Office
• Fluent in English, excellent writing skills.
• Willing to perform repetitive tasks
• Ability to analyze and understanding of investigations tools
• Good team player and good communicator
• Well-organized, rigorous and independent
• Engaged and future oriented