• Quality Assurance Engineer

    Job Locations US-RI-Pawtucket
    Job ID
    2018-1442
    Category
    Quality/Regulatory Affairs
    Type
    Full-Time/Regular
  • Overview

    ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.

     

    We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!

    Responsibilities

    • Lead product quality investigations to a successful conclusion
    •  Execute risk assessments, collect supporting information and provide recommendations for management consideration 
    • Lead departmental effort in CAPA investigation and completion 
    • Interface with other departments to provide guidance on CAPA completion  
    • Provide technical guidance to QA and QC personnel 
    • Represent quality interests and concerns on project teams 
    • Support manufacturing, new product development, and regulatory to ensure systems are compliant with all internal and external requirements Investigate causes of quality problems identified at incoming inspection, manufacturing and final QC inspection 
    • Collect, analyze, trend and communicate quality data throughout the organization 
    • Identify and help facilitate continuous improvement, corrective and preventive actions. 
    • Resource in Engineering Change Order review process 
    • Mentoring, education and training of QA personnel 
    • Assume additional responsibilities as necessary at the discretion of QA Management. 
    • Develop programs and methodologies for analyzing and presenting quality system data 
    • Identify program opportunities for improvement and drive procedure updates when required 
    • Oversee calibration program 
    • Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), ISO, and FDA requirements

    Qualifications

    • 3-5 years related experience in a regulated environment, preferably medical device 
    • Proficiency with MS Office 
    • Familiarity with use of mechanical and electrical test equipment 
    • Knowledge of commonly used concepts, practices, and procedures related to medical device manufacturing 
    • Ability to analyze and aggregate data using statistics 
    • Experience preferred with ISO 13485, ISO 14971 and FDA QSR for Medical Devices

    Education:

    •  Four Year degree, preferably in a technical discipline

     

    Other Duties:

     

    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification.

     

    ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Opportunity Employer M/F/D/V. 

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