Cantel Medical

  • QA Supervisor

    Location IT-Pomezia
    Job ID
    2018-4007
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    Cantel Italy
  • Company Overview

    Cantel Medical is a leading global company dedicated to delivering innovative infection prevention and control products and services for patients, caregivers, and other healthcare providers, which improve outcomes, enhance safety and help save lives.  Our products include specialized medical device reprocessing systems for endoscopy and renal dialysis, advanced water purification equipment, sterilants, disinfectants and cleaners, sterility assurance monitoring products for hospitals and dental clinics, disposable infection control products primarily for dental and GI endoscopy markets, dialysate concentrates, hollow fiber membrane filtration and separation products. Additionally, we provide technical service for our products. 

    Job Overview

    Provide quality assurance support to Manufacturing Operations by resolving quality related issues, improving product quality and investigating customer complaints and supplier non-conformances for Chemistry products and EM machines. Prepare and manage audit activities, maintaining accurate audit documentation to track and manage audit findings.
    Utilize risk-based approach to the control of processes and CAPA system to pursue continuous improvement of the Quality System and Cantel Medical products.

    Main Responsibilities

    • Ensure product complaints are promptly investigated and, where needed, adequate corrective/preventive actions are accordingly raised and implemented. Share complaints trend and data across company sites/locations.
    • Manage process and product NCs (including support to management of raw materials/components issues raised in Incoming and Production areas).
    • Writes and revises standard operating procedures (SOPs) and work instructions to incorporate agency regulations and ensure proper procedures are followed by site Personnel.
    • Implementation and maintenance of the quality management system in accordance with ISO13485:2016, ISO9001:2015, EU GMP, GDP Guidelines.
    • Interacts with other departments to consult on potential business opportunities and possible compliance issues and risks.
    • Corrective Action and Preventative Actions (CAPA).
    • Manages and performs internal audits, internal audit interaction, and recording of information and observations to track and trend audit findings, take corrective/preventative actions, and maintain proof of audits and documentation.
    • Implements and manages change control procedures, training, and audits and participates in writing and revising procedures identified through the validation process to ensure validation is maintained.
    • Participate to FMEAs definition.
    • Manages and performs the gathering of information and documentation to participate and support QA Manager during third party audits (held by Notified Body, MoH Agency).
    • Manages and implements training programs and materials to train site Personnel on SOPs and work instructions. Ensure personal training records are maintained in conjunction with HR department.
    • Support the QA Manager to gather and trend quality data for periodic review and Quality Management Reviews.

    Qualifications

     

     

    •  Master degree in Engineering or Life Sciences.
    • Knowledge and experience with ISO13485, ISO9001 and GMP requirements.
    • Fluent English language.
    • Experience in third party audit activities.
    • Good knowledge of Microsoft.
    • Good interpersonal and professional communication skills.
    • Strong organizational skills and service oriented.
    • Team working and Problem Solving.

    Minimum Qualifications

     Required 3 – 5 years of experience in QA department.

    Preferred Qualifications

     

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