Cantel Medical

  • Senior Quality Compliance Specialist

    Location US-NY-Rochester
    Job ID
    2018-4387
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    Cantel Dental
  • 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.

    Job Overview

    The Quality System Compliance Specialist leads Cantel Medical Quality System activities by developing and implementing quality system processes and monitoring quality system compliance under the direction of the Cantel Global Quality System Compliance Director. Collaborate with Cantel Medical divisional QA and RA Leadership and functional teams to ensure substantial compliance to the Cantel quality systems, identifying opportunities for continuous improvement, and ensure appropriate resources are in place to support business needs and maintain compliance. Act as subject matter expert (SME) for the Cantel Medical Quality System software platform.

    Main Responsibilities

    • Work with Cantel Director Global Quality System Compliance to assure quality systems are in compliance with ISO 13485, FDA QSR Part 820, MDSAP and other applicable regulatory standards.
    • Manage day to day QMS activities such as CAPA, Documentation Control, Change Orders, Training, coordinate completion of audit responses and assist in NCMRs, risk assessment and other QMS related activities as needed.
    • Assemble data, schedule review, lead management review meeting, assign and drive to completion action items from review meetings
    • Responsible for executing site-specific electronic QMS validation activities as needed.
    • Main point of contact and support for internal and external audits/inspections.
    • This position has cross accountability and interactions with Cantel Divisional Leadership, Regulatory Affairs, Quality Assurance, Manufacturing, Engineering, Supply Chain, Research and Development, and Sales and Marketing.
    • Proactively investigate and support opportunities for the continued development of new quality programs/systems based on direction from Cantel Director Global Quality System Compliance.
    • Facilitate a teamwork atmosphere to urgently resolve compliance issues when they arise.
    • Update job knowledge by keeping abreast of trends and developments in quality assurance, ISO 13485 quality systems, and participating in educational opportunities.

    Qualifications

    • BA or BS degree required, Diploma holder in Life Sciences or Bioengineering
    • Minimum of 5 in Quality Systems experience in a regulated life science environment
    • Substantial experience in responsibility for compliance to FDA and ISO regulations
    • Must be knowledgeable and able to operate under cGMP, cGLP and ISO 13485 regulations
    • Proficient in computer skills such as MS office programs
    • Sterilization and/or microbiology background is preferred
    •  

    IDEAL CANDIDATE PROFILE:
    Personal Characteristics:

    • Strong written and oral skills
    • Strong organizational and management skills
    • Strong problem solving skills
    • Strong attention to detail

    #CB

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