Cantel Medical

  • Quality Engineer

    Location UK
    Job ID
    2019-4727
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    Cantel Southend
  • 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

    Job Title: Post- Market Quality Engineer
    Reports to : Quality Assurance Manager
    Location: Southend On Sea, Essex
    Duration of Contract: 6 months (day rate would vary depending on experience)

    The Post-Market Quality Engineer works cross-functionally with quality, operations, sales, field service, and sustaining engineering to support products that have been released to the field. This position plays a critical role for the business by investigating customer feedback and performing product performance monitoring and trending. In this role you will conduct product performance investigations that will lead to design, manufacturing and use improvements. This position will ensure product performance trends are distributed on a recurring basis for leadership review as part of the management review process.

    Qualifications

    • Bachelor’s Degree in technical or life sciences, or engineering.
    • Complaint handling experiencein a regulated environment
    • 2-5 years Quality Engineer experience.
    • Proficiency in MS Word, Excel, Access. Must read, write and understand English
    • Self-motivated and energetic
    • Strong interpersonal skills and ability to work / influence cross functional teams
    • Problem solving ability
    • Ability to prioritize effectively
    • Ability to multi-task in a fast-paced environment
    • Oral and written presentation skills

     

    Responsibilities

     

    • Participate in the complaint handling process by leading complaint investigations.
    • Apply engineering judgement and product knowledge to properly assess returned devices.
    • Perform complaint investigations, including, as appropriate, decontaminate and analyze returned devices, determine root cause, identify non-conformances, initiate health risk assessments, and generate reports and trends
    • Proactively work with other departments (R&D, Manufacturing, Quality, Design Assurance, Marketing, Regulatory, Field Service) to review returned devices and root causes, as necessary, to support investigations.
    • Meet goals and metrics to timely and accurately complete investigations of complaints in support of medical device regulatory reporting.
    • Identify high-level complaints or incidents that may have a significant impact on the business.
    • Proactively follow steps to judge escalation of high priority and/or complex product complaint investigations and corrective actions.
    • Perform or arrange for testing on complaint products, as necessary.
    • Support investigation into complaints of distributed devices and supplier-manufactured products/components, working with external contacts and Supplier Quality to facilitate their investigations.
    • Identify and implement changes to relevant QA monitoring programs to improve effectiveness and efficiency.
    • Perform data analysis to generate product performance trending reports for senior leadership review and decision-making.
    • Produce and maintain documentation in accordance with applicable regulations.
    • Participate in external audits and inspections as a subject matter expert on complaint investigations and returned product analysis.
    • Maintain quality system process for complaint investigations
    • Ensure predicate product performance is understood and provided to new product development teams.
    •  

    Preferred Qualifications

    • Experience with electromechanical equipment or injection molding products is a plus.
    • Working knowledge of FDA GMP/GLP, Medical Device Directive, and ISO
    • ASQ Quality Engineer and/or Six Sigma Green Belt certification a plus.

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