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.
Work Location: Rome – Italy – Viale Ostiense 131/L
Key Responsibilities
* Service Support:
o Oversee all processes related to the collection and review of the service records.
o Review the service activities related to medical device products and ensure the correct storage of records.
o Ensure that all service activities comply with regulatory standards, quality control protocols, and company policies.
o Review the service manual and all documentation provided to external parties used to carry out service activities.
* Equipment Management: Manage the equipment calibration and control the calibration expirations.
* Non-conformities Management: Open and manage the non-conformities issued during the service process, correction, and corrective action.
* Complaint Management: Manage the complaint activities. Ensure that activities are correctly carried out and registered.
* Problem Solving: Support the Lead Service Engineer in the implementation of the corrective actions to minimize disruptions. Ensure that activities are correctly carried out and registered.
* Training: Ensure that the training and guidance to external parties are correctly registered.
* Compliance: Support the Regulatory Affairs in compliance with all relevant regulations, including FDA, ISO, and other international standards.
* Internal Audit: Support the Quality Assurance Manager in the service process’s evaluation in compliance with all relevant regulations, including FDA, ISO, and other international standards.
Qualification – Required Knowledge, Skills and Abilities
* Knowledge of 2017/745 (MDR) and 21 CFR 820.
* Knowledge of 13485: 2021.
* Skills:
o Strong technical troubleshooting and problem-solving skills.
o Excellent communication and collaboration abilities.
o Good English level (writing and speaking).
* Personal Attributes:
o Ability to work independently and collaboratively across multifunctional teams.
o Resilient and able to work effectively under stress and tight deadlines.
o Willingness to travel as needed.
Minimum Required Education and Experience
* Experience: 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.
* Education: Bachelor’s degree in engineering, or a related field.
Physical Requirements
* Expected travel is 20%.
Apply
Email us attaching your CV, portfolio, and a motivational letter.
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