Cantel Medical

  • Quality Engineer

    Location US-MN-Plymouth
    Job ID
    2019-5196
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    Cantel Medical
  • 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.

    Main Responsibilities

    Provide quality engineering support to Manufacturing Operations and Continuation Engineering by resolving quality related issues, improving product quality, investigating customer complaints and managing sterilization processes used by the Filtration Focused Factory; 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; support Manufacturing Engineering to complete validations and conduct validations as it relates to quality of products for medical device industry; 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; investigate/analyze customer complaints and support Regulatory Affairs to monitor customer complaint trends and maintain compliance to complaint system; initiate, review, and approve disposition for Nonconforming Product and lead Material Review Board (MRB) teams; initiate supplier corrective actions and assist Purchasing to continuously improve supplier quality and enhance supplier relationships; initiate, 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 the Quality System and lead continuous improvement efforts of the Quality System; and facilitate customer audits and assist as needed with external audits such as FDA and ISO; utilize ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, Good Laboratory Practices, ISO 14971, sterilization standards, and statistical analysis, SPC, and Design of Experiments.

    Qualifications

    Bachelor’s degree in Mechanical Engineering, Quality Engineering or related engineering discipline, and 2 years of progressive post-baccalaureate engineering work experience as a Quality Assurance Engineer.

    1 year of experience in:

    • Good Manufacturing Practices, Good Laboratory Practices, ISO 14971
    • Sterilization standards
    • Statistical analysis, SPC, and Design of Experiments

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed