Cantel Medical

  • Quality Engineer

    Location US-AZ
    Job ID
    2019-5101
    # 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. #CB

     

    Job Overview

    Provide quality engineering support to Manufacturing Operations and R&D by resolving quality-related issues, improving product quality, investigating customer complaints and reducing costs. Utilize the Correction and Preventive Action system to pursue continuous improvement of the Quality System and products. Assist with supplier support and play an active role in cost reduction projects that support Lean initiatives. Represent Quality Assurance on Research and Development project teams. Support Manufacturing Engineering by reviewing validations as they relate to product quality.

    Main Responsibilities

    • Design and/or specify inspection and testing procedures/systems to ensure products conform to specifications and quality standards.
    • Investigate/analyze in-house and field failures (returns) and monitor quality trends. Propose and implement possible solutions/improvements utilizing the Corrective and Preventive Action (CAPA) system.
    • Participate in investigation and analysis of customer complaints as requested by Quality Engineer and Quality Engineering Technician.
    • Review and approve disposition for Nonconforming Product and participate in Material Review Board (MRB) team.
    • Review and approve Engineering Change Orders (ECO), Deviation Authorizations, Qualification/Validation Protocols, Final Qualification Protocol Reports, as well as Inspection Procedures.
    • Lead efforts to continuously improve product quality, while ensuring safety, efficacy and regulatory compliance.
    • Support all functional departments to ensure compliance with Quality System and lead continuous improvement efforts of the Quality System.
    • Represent Quality Assurance on product development teams, including developing Quality Plans and Risk Management Plans.
    • Be key participant in CAPA Committee and any Data Review Committees.
    • Interface with personnel from all areas of the company to foster improved quality and reduced cost.
    • 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.
    • When applicable, supervise work of Quality Assurance of QA Inspectors and QA Technicians as defined by QA Manager
    • Other related duties as assigned

    Qualifications

    • BS in Engineering and a minimum of 7 years’ experience in Engineering required
    • Prefer that the work experience is in the medical device industry as a Quality Assurance Engineer.
    • Prior experience in a facility with injection molding highly preferred
    • Practical experience/familiarity with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, ISO 14971 and other applicable standards.
    • Must possess practical knowledge related to products that the position will support, plastics and other molded parts.
    • Possess basic PC skills, and have working knowledge of Microsoft Word, Excel, and Access.
    • Must have practical knowledge and experience in statistical analysis, SPC, and Design of Experiments.
    • Must be able to properly use most inspection tools and test equipment.
    • Must be able to read and understand component/product specifications.
    • 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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