Cantel Medical

  • Post-Market Quality Specialist

    Location US-MN-Plymouth
    Job ID
    2019-5328
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    Cantel
  • Company Overview

    At Cantel, preventing infection is our business. We are dedicated to delivering high-quality, innovative solutions that help our customers improve patient care. Choosing a career with Cantel means joining a company that’s driven by an entrepreneurial spirit and the passion to shape the future of infection prevention. If you want to be inspired by your work and have a hand in shaping the future of infection prevention, we want to meet you. Come and see why people love working here.

     

    Cantel is a leading global company dedicated to delivering innovative infection prevention 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. Cantel medical is a leading provider of infection prevention products and services in the healthcare market, specializing in the following operating units:

     

    Medical 

    Endoscopy procedure disposables include single-use valves and irrigation tubing. Medical device reprocessing systems, disinfectants, detergents and other supplies are used to disinfect high-level endoscopes. This segment is operated through MEDIVATORS.

     

    Life Sciences 

    Water purification systems for dialysis facilities, including hemodialysis dialyzer and reprocessing systems, as well as sterilants and filtration products. This segment is operated through Mar Cor Purification, Inc. and MEDIVATORS.

     

    Dental 

    Single-use, infection prevention products used primarily in the dental market including face masks, sterilization pouches, towels and bibs, tray covers, saliva ejectors, germicidal wipes, plastic cups and disinfectants. This segment is operated through Crosstex International, Inc. #CB

    Job Overview

    The Post-Market Quality Specialist is responsible for coordinating recalls/field corrective actions in accordance with regulations. In addition to this, the Post-Market Quality Specialist will support and manage resolution of product issues and provide leadership with recall recommendations, recall effectiveness and quality metrics.

    Main Responsibilities

    • Support risk assessments to provide product recall recommendations to leadership.
    • Ensure proper assessments of product quality, safety and reliability issues and communicate to management and across functions.
    • Coordinate recalls by assembling a cross-functional recall team and organizing activities to ensure execution in accordance with regional regulations.
    • Support preparation of customer recall notifications, recall reports, and communications to regulatory agencies.
    • Monitor recall activities and provide upper leadership reports on effectiveness and efficiency of recall processes.
    • Track customer recall responses, documentation and file completion.
    • Work with cross-functional team to manage product quality issues and determine the appropriate path for resolution.
    • Coordinate risk management activities when new quality failure modes or product design changes are made.
    • Compile quality metrics for reports to site management and Quality Management Reviews.

    Qualifications

    • BA or BS degree (or equivalent experience) required, preferably in Life Sciences
    • Minimum of 2 years Quality experience in a life science environment
    • Experienced with responsibility for compliance to ISO regulations
    • Must be knowledgeable and able to operate under ISO 13485 regulations
    • Proficient in computer skills such as MS office programs
    • Ability to communicate issues with widely varied audience in a clear and credible manner
    • Strong attention to detail, ensures that work has been done according to procedures and standards

     

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