Quality Service Operations

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Solo per membri registrati
Latina
EUR 35.000 - 50.000
Sii tra i primi a mandare la candidatura.
6 giorni fa
Descrizione del lavoro

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 correct 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 implementing corrective actions to minimize disruptions. Ensure activities are correctly carried out and registered.
  • Training : Ensure that training and guidance to external parties are correctly registered.
  • Compliance : Support Regulatory Affairs in ensuring compliance with all relevant regulations, including FDA, ISO, and other international standards.
  • Internal Audit : Assist the Quality Assurance Manager in evaluating the service process’s 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 ISO 13485:2021.
    • Skills :

    Strong technical troubleshooting and problem-solving skills.

    • Excellent communication and collaboration abilities.
    • Proficiency in English (writing and speaking).
    • Personal Attributes :

    Ability to work independently and collaboratively across multifunctional teams.

    Resilient and capable of working effectively under stress and tight deadlines.

    Willingness to travel as needed.

    Minimum Required Education and Experience

    • Experience : At least 2 years in a quality assurance role within the medical devices or healthcare industry, focusing on service processes.
    • Education : Bachelor’s degree in engineering or a related field.

    Physical Requirements

    • Expected travel: 20%.

    Apply

    Email us attaching your CV, portfolio, and a motivational letter.

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