Quality Service Operations

Purpose

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:
  • 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
• 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 parts are correctly registered
• Compliance: Support the Regulatory Affairs in the 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:
  • Strong technical troubleshooting and problem-solving skills.
  • Excellent communication and collaboration abilities.
  • Good English Level (writing and speaking)
• Personal Attributes:
  • 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 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%