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Regulatory QE

Req ID: J2292792

  • Location
    Uzhgorod, Zakarpattia Oblast, Ukraine
  • Category Quality Group
  • Posted Wednesday, October 27, 2021
  • Time Type Full time
  • Job Type Permanent Employee

Job Description

Participates in system and device product development teams to ensure regulatory, quality, and safety standards are incorporated into product specifications and manufacturing processes.
·         Works with customers and Business Units to create Quality and Manufacturing plans providing clear, unambiguous, and mutual understanding of responsibilities and requirements for Jabil service(s) provided.
·         Works with design and process engineers to develop risk assessments.
·         Supports sales presentations, contract reviews, and quoting.
·         Coordinates regulatory compliance aspects of product launch.  
·         Collaborates with the customer and internal engineering teams to continuously improve engineering services and regulatory compliance of the devices manufactured.
·         Identifies and ensures compliance with all laws and regulations that apply to medical device manufacturers.
·         Provides fellow employees and customers with guidance and support to ensure compliance with GMP and the QSR.
·         Supports internal, external, and regulatory audits with the FDA.
·         Helps define and develop regulatory, quality, and safety training for the plant.
·         May perform other duties and responsibilities as assigned.
·         Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
·         Ability to define problems, collect data, establish facts, and draw valid conclusions. 
·         Ability to operate a personal computer including using a Windows based operating system and related software. 
·         Advanced PC skills, including training and knowledge of Jabil’s software packages. 
·         Ability to write simple correspondence.  Read and understand visual aid. 
·         Ability to apply common sense understanding to carry out simple one- or two-step instructions.  
·         Ability to deal with standardized situations with only occasional or no variables.
·         Ability to read and comprehend simple instructions, short correspondence, and memos.  
·         Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.  
·         Ability to compute rate, ratio, and percent and to draw and interpret graphs.

Accessibility Accommodation

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to or by calling 1.727.803.7515 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address and/or phone number.

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