Cantel Medical

  • Director Quality Assurance

    Location US-NY-Rochester | US-NY-Hauppauge
    Job ID
    2018-3894
    # 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

    Provide leadership for Crosstex Quality Assurance and Quality Control functions that supports Crosstex products and operational processes. Ensure compliance in all quality activities by managing the Crosstex Quality Systems. Facilitate collaboration among Operational groups to maintain quality system compliance, achieve company and departmental objectives, and sustain continuous improvement. Support Crosstex strategic objectives by strategically planning and managing Quality Assurance resources.

    Main Responsibilities

    • Provide vision and leadership within and external to areas of responsibility. Contribute to the development of personal within the Quality Assurance team.  Act as a mentor to provide motivation, career guidance and professional development within the QA organization
    • Maintain clear and open communication between Quality Assurance and other functional leads.
    • Develop long and short-term plans projecting quality assurance plans, programs and objectives, including capital and operating budgets.
    • Maintain compliance with FDA and ISO requirements.  This includes being part of the team for FDA and ISO audits.
    • Coordinate quality assurance efforts by encouraging a teamwork approach with Operations, Research and Development, Regulatory, Marketing and Sales and facilitate an atmosphere of prompt resolution to issues when they arise.
    • Work collaboratively with Cantel Director of Global Quality System Compliance and Functional leaders to ensure adherence of Crosstex Quality Systems.
    • Direct cross-functional efforts to improve the quality system and assure suitability with all products.
    • Organize and schedule Quality Management Reviews as required by the Quality System.
    • Participate in Crosstex Leadership meetings. 

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    Qualifications

    • BA or BS degree in a technical discipline, with a minimum of 7 years’ experience in the medical device industry is required. 
    • Masters in Business or Field of study preferred.
    • Background in sterilization or healthcare disposables preferred.
    • Must have a sound understanding of how to lead a multi discipline team. 
    • Must have a sound understanding of manufacturing operations.
    • Must have strong problem solving skills.
    • Strong written and oral skills, together with strong organizational and management skills are a must.
    • Must be knowledgeable and able to operate under FDA Part 820, ISO 13485 and cGMP, cGLP regulations.
    • Responsive and reliable, with exceptional follow-through.
    • Ability to work both independently and as a team player.

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