Cantel Medical

  • Validation Engineer

    Location US-NY-Rochester
    Job ID
    2019-5022
    # 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 validation support to Cantel Medical, Dental Division facilities. This position is responsible for validation deliverables to meet the needs of customers, projects, and commercial production. This position is responsible for
    nsuring that the validation activities are performed to the appropriate levels of cGMP, ISO and FDA compliance. Write and execute validation documents for equipment, instruments, facilities, utilities, processes, and test methods in
    ccordance with the Site Validation Master Plan, project specific Validation Plans, and departmental SOPs. The position is also responsible for the analysis of data, completion of validation protocols, and protocol and validation plan summary reports. Participation on various project teams will be required. The Validation Engineer provides validation guidance and training to operations. The Validation Engineer manages documentation for validation qualification
    rocedures and technical reports including IQ/OQ/PQ.

    Main Responsibilities

    • Assists with the creation of and reviews validation and /or qualification procedures and technical reports associated with both process validation and equipment qualification activities.
    • Creates validation reports to ensure compliance with ISO and FDA regulation requirements. Provide ISO 13485 and FDA regulation guidance to all site disciplines.
    • Writes/revises or reviews /approves validation lifecycle documents. Document types include but are not limited to validation plans, validation protocols, equipment qualification (IQ/OQ/PQ), process validation, cleaning validations, requirement specifications, method validations, SOPs, work instructions and forms, investigations, validation deviations, CAPAs, any pertinent test data, and validation reports.
    • Design and/or specify inspection and testing procedures/systems to ensure products conform to specifications and quality standards.
    • Participate with investigation and analysis of customer complaints as requested by Quality Engineer and Quality Engineering Technician.
    • Leads / participates in the preparation of risk assessments using tools such as Process/Design Failure Mode and Effects Analysis (PFMEA /DFMEA).
    • Assist with execution and development of Validation Master Plans.
    • Interact and coordinate with compliance efforts across departments including, but not limited to: Operations, Engineering, Quality, and development functions to provide a high degree of assurance that all qualification/validation activities are completed to requirements.
    • Manage and approve deviations and change requests related to systems, equipment, manufacturing processes and facilities related to any potential validation activity/status.
    • Lead efforts to continuously improve product quality, while ensuring safety, efficacy and regulatory compliance.
    • Support all functional departments to ensure compliance with the Quality System and lead continuous improvement efforts of the Quality System.
    • Interface with personnel from all areas of the company to foster improved quality and reduced cost.

    Qualifications

    • BS in Engineering, with a minimum of 7 years’ relevant experience is required.
    • Experience in medical device industry, sterilization or biological indicators preferred.
    • Practical experience/understanding of manufacturing operations, including knowledge of US-FDA medical device regulations and EU Medical Device Directive, and ISO 13485 requirements, as well as familiarity ISO 11138 sterility assurance requirements.
    • Strong background in validation, statistical analysis, SPC, Design of Experiments, and statistical tools such as Sampling Plans, Experimental Design and Optimization.
    • Must be able to properly use most inspection tools and test equipment.
    • Must be able to read and understand component/product specifications.
    • Possess basic PC skills, and have working knowledge of Microsoft Word, Excel, and Access.
    • Must be highly organized and have the ability to manage multiple projects concurrently.
    • Must possess good written and verbal communication skills as well as team building skills

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