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Join the Quality Service Operations team to uphold the highest standards of quality and compliance in post-market support, ensuring exceptional service and reliability for life-saving medical devices.
Job Responsibility:
Oversee all processes related to the collection and review of the service records
Review the service activities related to medical device products and ensure the correctly storage of records
Ensure that all service activities comply with regulatory standards, quality control protocols, and company policies
Review the service manual and all documentation provided to external parties used to carry out service activities
manage the equipment calibration and control the calibration expirations
open and manage the non conformities issued during the service process, correction and corrective action
manage the complaint activities
support the Lead Service Engineer in the implementation of the corrective actions to minimize disruptions
ensure that the training and guidance to external parts are correctly registered
Support the Regulatory Affairs in the compliance with all relevant regulations, including FDA, ISO, and other international standards
Support the Quality Assurance Manager in the service process’s evaluation in compliance with all relevant regulations, including FDA, ISO, and other international standards
Requirements:
Knowledge of 2017/745(MDR) and 21 CFR 820
Knowledge of 13485: 2021
Strong technical troubleshooting and problem-solving skills
Excellent communication and collaboration abilities
Good English Level (writing and speaking)
Ability to work independently and collaboratively across multifunctional teams
Resilient and able to work effectively under stress and tight deadlines
Willingness to travel as needed
Minimum of 2 years of experience in the quality assurance role within the medical devices or healthcare industry, with a strong focus on service processes
Bachelor’s degree in engineering, or a related field
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